Barrett EsophagusNCT02396745
TECR & ECM Placement for Esophageal High Grade Dysplasia
A study testing Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)) in people with Barrett Esophagus and Esophagus, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett Esophagus, Esophagus, High Grade Dysplasia
- What is being tested?
- Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2016to 22 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age and no more than 80 years of age.
- Have an established diagnosis of HGD
- Specific diagnosis and grading will be determined by pathology review of biopsy tissue collected during baseline EGD as part of a patient's standard of care.
- Have no evidence of lymphovascular invasion.
- Have no lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
- Diameter of affected tissue must warrant circumferential excision a. Subjects must have biopsy confirmed HGD in three of four esophageal quadrants at two levels spaced two centimeters apart (minimum of 6/8 biopsies indicating HGD). If two biopsies are normal (contain no HGD) they must be located on separate levels in two different quadrants.
- 5. Must be an appropriate or reasonable surgical candidate. 6. Have demonstrated an understanding and signed an approved informed consent form for participation in this study.
Who cannot join
- Have lesions into or deeper than mucosal layer (superficial (T1a) Esophageal adenocarcinoma).
- Those requiring endoscopic submucosal dissection (ESD) are not eligible for this study
- Have presence of lymphovascular invasion.
- Require resection length longer than 10 cm.
- Have any lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
- Have history of any kind of previous esophageal surgery (i.e. anti-reflux surgery).
Show all 13Show fewer
- Are pregnant or planning to become pregnant.
- Have coagulation disorders.
- Have a known hypersensitivity to porcine-based materials.
- Have an uncontrolled comorbid medical condition that would adversely affect participation in the trial.
- Has a clinically significant psychological illness that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
- Are unable or unwilling to provide informed consent and/or fulfill the protocol follow-up requirements.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
West Penn Allegheny Health System
Pittsburgh, Pennsylvania, 15224
About this study
Official title: A Prospective Feasibility Study to Evaluate the Safety and Efficacy of Transoral Endoscopic Circumferential Esophageal Resection With Extracellular Matrix (ECM) Placement to Treat Barrett's Esophagus With High-grade Dysplasia (HGD)
This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential resection using ECM placement has been introduced as a less invasive, externally incision-less approach to treat patients with esophageal high grade dysplasia; a pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa (esophagus lining) will be removed using an endoscope that will be inserted through the mouth. The ECM will be placed over the area that is being removed with a temporary, expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the ECM in place as the body begins the healing process. This stent will be removed 14 days (±4 days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow x-ray tests, and questionnaires will take place for 12 months following the procedure. The result of this study may help doctors determine if this procedure would be a more effective treatment option for HGD in the future.
Read the detailed description
This is a single-center, prospective, single arm study involving 10 patients with an established diagnosis of Barrett's Esophagus (BE) with High Grade Dysplasia (HGD). Potential subjects will be prescreened to assess eligibility and must meet inclusion criteria. In order to make this initial qualification, pathology results of biopsies and EMR collected during initial EGD will be made available to the Investigator prior to patient consent. Following informed consent and as part of routine care, all potential participants will undergo endoscopic ultrasound (EUS) and a PET/CT scan to confirm that there is no lymph node involvement or other metastatic lesions prior to the procedure. Clinical data will be collected at baseline to assess the subjects' medical status including: demographics, medical history, physical examination, vital signs, and blood testing. Cardiac and pulmonary clearance will be obtained if needed based on medical history and will include a chest x-ray, ECG, and pulmonary function test. In addition, the subjects will complete three questionnaires prior to the procedure: dysphagia severity questionnaire, SF-36, and GERD-HRQL.
At the time of the procedure, participants will undergo TECR with ECM placement using a fully covered self-expanding metal stent to temporarily hold the ECM in place. Prior to hospital discharge, a barium swallow test (BaSW) will be performed at Day 1 following the study procedure to evaluate the passage of contrast through the GEJ. If the BaSW results in suspicious findings of esophageal perforation or mucosal necrosis, an upper endoscopy will be performed for further evaluation. The first primary safety endpoint for this study will be assessed following the procedure and BaSW and before discharge from the hospital. At this time point any adverse events will be assessed and recorded.
All subjects will undergo the same follow-up procedures, including questionnaires and post-procedure EGDs performed at Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 to visually assess tissue healing, recurrent disease, and if stricture formation is present. Biopsies will be taken during follow-up EGDs so that pathology can rule out recurrence of BE and HGD. Subjects will have a barium swallow x-ray at Month 1, Month 3, Month 6, Month 9, and Month 12 to evaluate the potential presence of stricture formation.
During Week 2 EGD, the stent will be removed during the upper endoscopy. If at any time point a subject has dysphagia with stricture formation (30% reduction in esophageal luminal diameter), routine dilation using a balloon catheter will be performed during the EGD. Validated questionnaires including dysphagia severity questionnaire, SF-36 and GERD-HRQL will be administered to objectively assess the severity of symptoms and quality of life based upon self-reported data. Additionally, adverse events will be assessed and recorded at all follow-up time points.
After completion of the Month 12 visit, subjects will be followed on a routine care basis at the Esophageal \& Lung Institute.
- Conditions
- Barrett Esophagus, Esophagus, High Grade Dysplasia
- Being tested
- Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))Device
Also called ACell, Inc. MatriStem® Surgical Matrix PSMX, Boston Scientific, WallFlex™ Fully Covered Esophageal Stent
TECR will be performed to resect the entire length and area of BE lesion.
ECM PLACEMENT:
Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA).
| Study group | Role | What they receive |
|---|---|---|
| TECR & ECM | Experimental | Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM) Receives: Device: Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Stricture Formation
To evaluate incidence of stricture formation requiring dilation (≥30% luminal diameter reduction with dysphagia) following TECR with ECM placement. Evidence of stricture formation will be confirmed endoscopically at 2 weeks, and endoscopically and through barium swallow at Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without stricture formation at the trial endpoints will be compared to historical data.
Measured: 12 months following procedure
Efficacy: Recurrent Disease
To evaluate incidence of recurrence of BE with HGD through 12 months following TECR with ECM placement. Incidence of disease recurrence will be confirmed endoscopically with pathology confirmed biopsies at 2 weeks, Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without disease recurrence at the trial endpoints will be compared to historical data.
Measured: 12 months following procedure
Safety: Acute (Serious System and Procedure Related Adverse Events)
To demonstrate the acute safety of TECR with ECM placement for treatment of BE with HGD by evaluating all serious system and procedure related adverse events occurring in the first 2 weeks post procedure.
Measured: Two weeks following procedure
Safety: Long-term (Study Related Adverse Events)
To demonstrate the long-term safety of TECR with ECM placement for treatment of BE with HGD by evaluating all study related adverse events occurring more than 2 weeks post procedure through 12 months post procedure.
Measured: Two weeks through 12 months post procedure
Secondary outcomes (3)
Stent Migration
To record the incidence of stent migration at 2 weeks post procedure. Stent migration will be determined endoscopically, and defined as any movement from initial deployment location greater than 1cm.
Measured: 2 weeks
Stent Integrity (e.g. Stent Fracture)
To record incidences of poor stent integrity during removal (e.g. stent fracture).
Measured: 2 weeks
Additional Interventions (Number of Subsequent Follow up Treatment Interventions)
To record the number of subsequent follow up treatment interventions (aside from study-related follow up time points) required post-procedure through 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start25 Jan 2016
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Why it stopped: Serious Adverse Event of Patient who completed study and follow-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, Blair Jobe, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396745
- Sponsor's protocol ID
- 12-024
- Status last verified
- Feb 2019
- First submitted
- 19 Mar 2015
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rice TW, Zuccaro G Jr, Adelstein DJ, Rybicki LA, Blackstone EH, Goldblum JR. Esophageal carcinoma: depth of tumor invasion is predictive of regional lymph node status. Ann Thorac Surg. 1998 Mar;65(3):787-92. doi: 10.1016/s0003-4975(97)01387-8.
PubMed 9527214Witteman BP, Foxwell TJ, Monsheimer S, Gelrud A, Eid GM, Nieponice A, O'Rourke RW, Hoppo T, Bouvy ND, Badylak SF, Jobe BA. Transoral endoscopic inner layer esophagectomy: management of high-grade dysplasia and superficial cancer with organ preservation. J Gastrointest Surg. 2009 Dec;13(12):2104-12. doi: 10.1007/s11605-009-1053-x. Epub 2009 Oct 14.
PubMed 19826883Badylak SF, Vorp DA, Spievack AR, Simmons-Byrd A, Hanke J, Freytes DO, Thapa A, Gilbert TW, Nieponice A. Esophageal reconstruction with ECM and muscle tissue in a dog model. J Surg Res. 2005 Sep;128(1):87-97. doi: 10.1016/j.jss.2005.03.002.
PubMed 15922361Nieponice A, Gilbert TW, Badylak SF. Reinforcement of esophageal anastomoses with an extracellular matrix scaffold in a canine model. Ann Thorac Surg. 2006 Dec;82(6):2050-8. doi: 10.1016/j.athoracsur.2006.06.036.
PubMed 17126109Nieponice A, McGrath K, Qureshi I, Beckman EJ, Luketich JD, Gilbert TW, Badylak SF. An extracellular matrix scaffold for esophageal stricture prevention after circumferential EMR. Gastrointest Endosc. 2009 Feb;69(2):289-96. doi: 10.1016/j.gie.2008.04.022. Epub 2008 Jul 26.
PubMed 18657808Badylak SF, Hoppo T, Nieponice A, Gilbert TW, Davison JM, Jobe BA. Esophageal preservation in five male patients after endoscopic inner-layer circumferential resection in the setting of superficial cancer: a regenerative medicine approach with a biologic scaffold. Tissue Eng Part A. 2011 Jun;17(11-12):1643-50. doi: 10.1089/ten.TEA.2010.0739. Epub 2011 Mar 28.
PubMed 21306292Hoppo T, Badylak SF, Jobe BA. A novel esophageal-preserving approach to treat high-grade dysplasia and superficial adenocarcinoma in the presence of chronic gastroesophageal reflux disease. World J Surg. 2012 Oct;36(10):2390-3. doi: 10.1007/s00268-012-1698-6.
PubMed 22736346Buscaglia JM, Ho S, Sethi A, Dimaio CJ, Nagula S, Stavropoulos SN, Gonda TA, Poneros JM, Stevens PD. Fully covered self-expandable metal stents for benign esophageal disease: a multicenter retrospective case series of 31 patients. Gastrointest Endosc. 2011 Jul;74(1):207-11. doi: 10.1016/j.gie.2011.02.024. Epub 2011 May 6. No abstract available.
PubMed 21549373Liu J, Hu Y, Cui C, Li Y, Lin X, Fu J. Removable, fully covered, self-expandable metal stents for the treatment of refractory benign esophagogastric anastomotic strictures. Dysphagia. 2012 Jun;27(2):260-4. doi: 10.1007/s00455-011-9361-1. Epub 2011 Aug 9.
PubMed 21826422Bakken JC, Wong Kee Song LM, de Groen PC, Baron TH. Use of a fully covered self-expandable metal stent for the treatment of benign esophageal diseases. Gastrointest Endosc. 2010 Oct;72(4):712-20. doi: 10.1016/j.gie.2010.06.028.
PubMed 20883848Eloubeidi MA, Lopes TL. Novel removable internally fully covered self-expanding metal esophageal stent: feasibility, technique of removal, and tissue response in humans. Am J Gastroenterol. 2009 Jun;104(6):1374-81. doi: 10.1038/ajg.2009.133. Epub 2009 Apr 28.
PubMed 19491851Yoon CJ, Shin JH, Song HY, Lim JO, Yoon HK, Sung KB. Removal of retrievable esophageal and gastrointestinal stents: experience in 113 patients. AJR Am J Roentgenol. 2004 Nov;183(5):1437-44. doi: 10.2214/ajr.183.5.1831437.
PubMed 15505317Baron TH, Burgart LJ, Pochron NL. An internally covered (lined) self-expanding metal esophageal stent: tissue response in a porcine model. Gastrointest Endosc. 2006 Aug;64(2):263-7. doi: 10.1016/j.gie.2006.03.936.
PubMed 16860080Sharma P, Kozarek R; Practice Parameters Committee of American College of Gastroenterology. Role of esophageal stents in benign and malignant diseases. Am J Gastroenterol. 2010 Feb;105(2):258-73; quiz 274. doi: 10.1038/ajg.2009.684. Epub 2009 Dec 22.
PubMed 20029413Hirdes MM, Siersema PD, Houben MH, Weusten BL, Vleggaar FP. Stent-in-stent technique for removal of embedded esophageal self-expanding metal stents. Am J Gastroenterol. 2011 Feb;106(2):286-93. doi: 10.1038/ajg.2010.394. Epub 2010 Oct 12.
PubMed 20940709
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study to Evaluate the Safety and Efficacy of Transoral Endoscopic Circumferential Esophageal Resection With Extracellular Matrix (ECM) Placement to Treat Barrett's Esophagus With High-grade Dysplasia (HGD)
- ClinicalTrials.gov ID
- NCT02396745
- Acronym / sponsor ID
- 12-024
- Conditions
- Barrett Esophagus, Esophagus, High Grade Dysplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Serious Adverse Event of Patient who completed study and follow-up.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Posted 19 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential resection using ECM placement has been introduced as a less invasive, externally incision-less approach to treat patients with esophageal high grade dysplasia; a pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa (esophagus lining) will be removed using an endoscope that will be inserted through the mouth. The ECM will be placed over the area that is being removed with a temporary, expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the ECM in place as the body begins the healing process. This stent will be removed 14 days (±4 days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow x-ray tests, and questionnaires will take place for 12 months following the procedure. The result of this study may help doctors determine if this procedure would be a more effective treatment option for HGD in the future.
Detailed description
This is a single-center, prospective, single arm study involving 10 patients with an established diagnosis of Barrett's Esophagus (BE) with High Grade Dysplasia (HGD). Potential subjects will be prescreened to assess eligibility and must meet inclusion criteria. In order to make this initial qualification, pathology results of biopsies and EMR collected during initial EGD will be made available to the Investigator prior to patient consent. Following informed consent and as part of routine care, all potential participants will undergo endoscopic ultrasound (EUS) and a PET/CT scan to confirm that there is no lymph node involvement or other metastatic lesions prior to the procedure. Clinical data will be collected at baseline to assess the subjects' medical status including: demographics, medical history, physical examination, vital signs, and blood testing. Cardiac and pulmonary clearance will be obtained if needed based on medical history and will include a chest x-ray, ECG, and pulmonary function test. In addition, the subjects will complete three questionnaires prior to the procedure: dysphagia severity questionnaire, SF-36, and GERD-HRQL.
At the time of the procedure, participants will undergo TECR with ECM placement using a fully covered self-expanding metal stent to temporarily hold the ECM in place. Prior to hospital discharge, a barium swallow test (BaSW) will be performed at Day 1 following the study procedure to evaluate the passage of contrast through the GEJ. If the BaSW results in suspicious findings of esophageal perforation or mucosal necrosis, an upper endoscopy will be performed for further evaluation. The first primary safety endpoint for this study will be assessed following the procedure and BaSW and before discharge from the hospital. At this time point any adverse events will be assessed and recorded.
All subjects will undergo the same follow-up procedures, including questionnaires and post-procedure EGDs performed at Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 to visually assess tissue healing, recurrent disease, and if stricture formation is present. Biopsies will be taken during follow-up EGDs so that pathology can rule out recurrence of BE and HGD. Subjects will have a barium swallow x-ray at Month 1, Month 3, Month 6, Month 9, and Month 12 to evaluate the potential presence of stricture formation.
During Week 2 EGD, the stent will be removed during the upper endoscopy. If at any time point a subject has dysphagia with stricture formation (30% reduction in esophageal luminal diameter), routine dilation using a balloon catheter will be performed during the EGD. Validated questionnaires including dysphagia severity questionnaire, SF-36 and GERD-HRQL will be administered to objectively assess the severity of symptoms and quality of life based upon self-reported data. Additionally, adverse events will be assessed and recorded at all follow-up time points.
After completion of the Month 12 visit, subjects will be followed on a routine care basis at the Esophageal \& Lung Institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TECR & ECM | Experimental | Device: Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))Subjects undergoing TECR with ECM placement Intervention is Trans-oral Endoscopic circumferential resection (TECR) with placement of extra-cellular matrix (ECM) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years of age and no more than 80 years of age.
- Have an established diagnosis of HGD
- Have no evidence of lymphovascular invasion.
- Have no lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
- Diameter of affected tissue must warrant circumferential excision a. Subjects must have biopsy confirmed HGD in three of four esophageal quadrants at two levels spaced two centimeters apart (minimum of 6/8 biopsies indicating HGD). If two biopsies are normal (contain no HGD) they must be located on separate levels in two different quadrants.
Key exclusion criteria (13 listed)
- Have lesions into or deeper than mucosal layer (superficial (T1a) Esophageal adenocarcinoma).
- Have presence of lymphovascular invasion.
- Require resection length longer than 10 cm.
- Have any lymph node or other metastatic involvement based on EUS and FDG-PET/CT.
- Have history of any kind of previous esophageal surgery (i.e. anti-reflux surgery).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))Also: ACell, Inc. MatriStem® Surgical Matrix PSMX, Boston Scientific, WallFlex™ Fully Covered Esophageal StentTECR will be performed to resect the entire length and area of BE lesion. ECM PLACEMENT: Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA). | Device | TECR & ECM |
Primary outcome
Efficacy: Stricture Formation
Time frame: 12 months following procedure
To evaluate incidence of stricture formation requiring dilation (≥30% luminal diameter reduction with dysphagia) following TECR with ECM placement. Evidence of stricture formation will be confirmed endoscopically at 2 weeks, and endoscopically and through barium swallow at Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without stricture formation at the trial endpoints will be compared to historical data.
Efficacy: Recurrent Disease
Time frame: 12 months following procedure
To evaluate incidence of recurrence of BE with HGD through 12 months following TECR with ECM placement. Incidence of disease recurrence will be confirmed endoscopically with pathology confirmed biopsies at 2 weeks, Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without disease recurrence at the trial endpoints will be compared to historical data.
Safety: Acute (Serious System and Procedure Related Adverse Events)
Time frame: Two weeks following procedure
To demonstrate the acute safety of TECR with ECM placement for treatment of BE with HGD by evaluating all serious system and procedure related adverse events occurring in the first 2 weeks post procedure.
Safety: Long-term (Study Related Adverse Events)
Time frame: Two weeks through 12 months post procedure
To demonstrate the long-term safety of TECR with ECM placement for treatment of BE with HGD by evaluating all study related adverse events occurring more than 2 weeks post procedure through 12 months post procedure.
3 secondary outcomes
Stent Migration
Time frame: 2 weeks
Stent Integrity (e.g. Stent Fracture)
Time frame: 2 weeks
Additional Interventions (Number of Subsequent Follow up Treatment Interventions)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9527214Rice TW, Zuccaro G Jr, Adelstein DJ, Rybicki LA, Blackstone EH, Goldblum JR. Esophageal carcinoma: depth of tumor invasion is predictive of regional lymph node status. Ann Thorac Surg. 1998 Mar;65(3):787-92. doi: 10.1016/s0003-4975(97)01387-8.
- Background: PubMed 19826883Witteman BP, Foxwell TJ, Monsheimer S, Gelrud A, Eid GM, Nieponice A, O'Rourke RW, Hoppo T, Bouvy ND, Badylak SF, Jobe BA. Transoral endoscopic inner layer esophagectomy: management of high-grade dysplasia and superficial cancer with organ preservation. J Gastrointest Surg. 2009 Dec;13(12):2104-12. doi: 10.1007/s11605-009-1053-x. Epub 2009 Oct 14.
- Background: PubMed 15922361Badylak SF, Vorp DA, Spievack AR, Simmons-Byrd A, Hanke J, Freytes DO, Thapa A, Gilbert TW, Nieponice A. Esophageal reconstruction with ECM and muscle tissue in a dog model. J Surg Res. 2005 Sep;128(1):87-97. doi: 10.1016/j.jss.2005.03.002.
- Background: PubMed 17126109Nieponice A, Gilbert TW, Badylak SF. Reinforcement of esophageal anastomoses with an extracellular matrix scaffold in a canine model. Ann Thorac Surg. 2006 Dec;82(6):2050-8. doi: 10.1016/j.athoracsur.2006.06.036.
- Background: PubMed 18657808Nieponice A, McGrath K, Qureshi I, Beckman EJ, Luketich JD, Gilbert TW, Badylak SF. An extracellular matrix scaffold for esophageal stricture prevention after circumferential EMR. Gastrointest Endosc. 2009 Feb;69(2):289-96. doi: 10.1016/j.gie.2008.04.022. Epub 2008 Jul 26.
- Background: PubMed 21306292Badylak SF, Hoppo T, Nieponice A, Gilbert TW, Davison JM, Jobe BA. Esophageal preservation in five male patients after endoscopic inner-layer circumferential resection in the setting of superficial cancer: a regenerative medicine approach with a biologic scaffold. Tissue Eng Part A. 2011 Jun;17(11-12):1643-50. doi: 10.1089/ten.TEA.2010.0739. Epub 2011 Mar 28.
- Background: PubMed 22736346Hoppo T, Badylak SF, Jobe BA. A novel esophageal-preserving approach to treat high-grade dysplasia and superficial adenocarcinoma in the presence of chronic gastroesophageal reflux disease. World J Surg. 2012 Oct;36(10):2390-3. doi: 10.1007/s00268-012-1698-6.
- Background: PubMed 21549373Buscaglia JM, Ho S, Sethi A, Dimaio CJ, Nagula S, Stavropoulos SN, Gonda TA, Poneros JM, Stevens PD. Fully covered self-expandable metal stents for benign esophageal disease: a multicenter retrospective case series of 31 patients. Gastrointest Endosc. 2011 Jul;74(1):207-11. doi: 10.1016/j.gie.2011.02.024. Epub 2011 May 6. No abstract available.
- Background: PubMed 21826422Liu J, Hu Y, Cui C, Li Y, Lin X, Fu J. Removable, fully covered, self-expandable metal stents for the treatment of refractory benign esophagogastric anastomotic strictures. Dysphagia. 2012 Jun;27(2):260-4. doi: 10.1007/s00455-011-9361-1. Epub 2011 Aug 9.
- Background: PubMed 20883848Bakken JC, Wong Kee Song LM, de Groen PC, Baron TH. Use of a fully covered self-expandable metal stent for the treatment of benign esophageal diseases. Gastrointest Endosc. 2010 Oct;72(4):712-20. doi: 10.1016/j.gie.2010.06.028.
- Background: PubMed 19491851Eloubeidi MA, Lopes TL. Novel removable internally fully covered self-expanding metal esophageal stent: feasibility, technique of removal, and tissue response in humans. Am J Gastroenterol. 2009 Jun;104(6):1374-81. doi: 10.1038/ajg.2009.133. Epub 2009 Apr 28.
- Background: PubMed 15505317Yoon CJ, Shin JH, Song HY, Lim JO, Yoon HK, Sung KB. Removal of retrievable esophageal and gastrointestinal stents: experience in 113 patients. AJR Am J Roentgenol. 2004 Nov;183(5):1437-44. doi: 10.2214/ajr.183.5.1831437.
- Individual participant dataSharing planned: No
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Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)) in people with Barrett Esophagus and Esophagus, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Stricture Formation (time frame: 12 months following procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396745, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.