Morbid ObesityPhase 2NCT01025076
Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma
A Phase 2 study testing StomaphyX in people with Morbid Obesity, run by University of Alberta at 1 site in Canada.
Trial summary
Executive Summary Aims and Hypotheses of the Study: The aim of the study will be to evaluate the safety, effectiveness and early outcome of the StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- StomaphyX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to May 2012
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- BMI 35 or greater with one or more comorbidities
- At least 2 years post-Roux-en-Y gastric bypass surgery
- At enrollment, has regained at least 15% of excess body weight loss
- Enlarged Stoma Diameter
- Enlarged gastric pouch
Show all 10Show fewer
- Completed successful nutritional screening and compliant with nutritional programs
- Completed successful cardiopulmonary evaluation
- Patient willing to cooperate with follow-up assessment tests
- Signed informed consent
Who cannot join
- Esophageal stricture or any anatomic conditions that preclude passage of transoral endoluminal instruments
- Has another causal factor for weight regain other than stoma or pouch dilatation such as non compliant with nutritional and exercise programs
- Portal hypertension
- Coagulation disorders or chronic use of anticoagulants
- Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma
Executive Summary
Aims and Hypotheses of the Study:
Read more
The aim of the study will be to evaluate the safety, effectiveness and early outcome of the StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric patients. The study will test a hypothesis that the StomaphyX procedure will be effective in promoting the loss of regained weight, reducing the risk for comorbidities and improving patients' quality of life.
Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20
Inclusion Criteria:
18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss.
Exclusion Criteria:
Esophageal stricture, or any anatomic conditions that preclude passage of transoral endoluminal instruments, has another causal factor for weight regain other than stoma or pouch dilatation, portal hypertension, coagulation disorders or chronic use of anticoagulants, any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient.
Intervention Treatment: Creation of multiple full-thickness plications within the gastric pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA)
Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL, uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay
- Conditions
- Morbid Obesity
- Being tested
- StomaphyX
- Keywords
- Enlarged gastric pouch and stoma, Post bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StomaphyXDevice
StomaphyX with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) is a transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.
| Study group | Role | What they receive |
|---|---|---|
| StomaphyX Group | Experimental | * Primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy.
* Patients also demonstrate a weight regain of 15% of excess body weight loss. Receives: Device: StomaphyX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Change in Body Weight
Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.
Measured: At 6 months comparing to baseline weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2012
- Study completionMay 2012
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 (23)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Shahzeer Karmali, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025076
- Sponsor's protocol ID
- Pro00008913
- Status last verified
- Jan 2017
- First submitted
- 2 Dec 2009
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Thompson CC, Slattery J, Bundga ME, Lautz DB. Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain. Surg Endosc. 2006 Nov;20(11):1744-8. doi: 10.1007/s00464-006-0045-0. Epub 2006 Oct 5.
PubMed 17024527Elder KA, Wolfe BM. Bariatric surgery: a review of procedures and outcomes. Gastroenterology. 2007 May;132(6):2253-71. doi: 10.1053/j.gastro.2007.03.057.
PubMed 17498516Fernandez AZ Jr, DeMaria EJ, Tichansky DS, Kellum JM, Wolfe LG, Meador J, Sugerman HJ. Experience with over 3,000 open and laparoscopic bariatric procedures: multivariate analysis of factors related to leak and resultant mortality. Surg Endosc. 2004 Feb;18(2):193-7. doi: 10.1007/s00464-003-8926-y. Epub 2003 Dec 29.
PubMed 14691697Higa KD, Boone KB, Ho T. Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients--what have we learned? Obes Surg. 2000 Dec;10(6):509-13. doi: 10.1381/096089200321593706.
PubMed 11175957Sugerman HJ. Bariatric surgery for severe obesity. J Assoc Acad Minor Phys. 2001 Jul;12(3):129-36.
PubMed 11851201Gould JC, Garren MJ, Starling JR. Lessons learned from the first 100 cases in a new minimally invasive bariatric surgery program. Obes Surg. 2004 May;14(5):618-25. doi: 10.1381/096089204323093381.
PubMed 15186628Higa KD, Boone K, Nimeri A, Tercero F, Jackson A, Khan A. Gastric bypass: increased restriction for poor weight loss. Surg Endosc. 2007 Nov;21(11):1922-3. doi: 10.1007/s00464-007-9540-1. No abstract available.
PubMed 17909900Kaplan LM, Klein S, Boden G, Brenner DA, Gostout CJ, Lavine JE, Popkin BM, Schirmer BD, Seeley RJ, Yanovski SZ, Cominelli F. Report of the American Gastroenterological Association (AGA) Institute Obesity Task Force. Gastroenterology. 2007 May;132(6):2272-5. doi: 10.1053/j.gastro.2007.03.061. No abstract available.
PubMed 17498517Overcash WT. Natural orifice surgery (NOS) using StomaphyX for repair of gastric leaks after bariatric revisions. Obes Surg. 2008 Jul;18(7):882-5. doi: 10.1007/s11695-008-9452-8. Epub 2008 Apr 26.
PubMed 18438622Cadiere GB, Buset M, Muls V, Rajan A, Rosch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Deviere J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9.
PubMed 18443855Cadiere GB, Rajan A, Germay O, Himpens J. Endoluminal fundoplication by a transoral device for the treatment of GERD: A feasibility study. Surg Endosc. 2008 Feb;22(2):333-42. doi: 10.1007/s00464-007-9618-9. Epub 2007 Dec 11.
PubMed 18071818Cadiere GB, Rajan A, Rqibate M, Germay O, Dapri G, Himpens J, Gawlicka AK. Endoluminal fundoplication (ELF)--evolution of EsophyX, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol. 2006;15(6):348-55. doi: 10.1080/13645700601040024.
PubMed 17190659Jobe BA, O'Rourke RW, McMahon BP, Gravesen F, Lorenzo C, Hunter JG, Bronner M, Kraemer SJ. Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease: the anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. Ann Surg. 2008 Jul;248(1):69-76. doi: 10.1097/SLA.0b013e31817c9630.
PubMed 18580209Deitel M, Gawdat K, Melissas J. Reporting weight loss 2007. Obes Surg. 2007 May;17(5):565-8. doi: 10.1007/s11695-007-9116-0. No abstract available.
PubMed 17658011Kolotkin RL, Crosby RD, Kosloski KD, Williams GR. Development of a brief measure to assess quality of life in obesity. Obes Res. 2001 Feb;9(2):102-11. doi: 10.1038/oby.2001.13.
PubMed 11316344
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma
- ClinicalTrials.gov ID
- NCT01025076
- Acronym / sponsor ID
- Pro00008913
- Conditions
- Morbid Obesity
- Keywords
- Enlarged gastric pouch and stoma, Post bariatric surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- Feb 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Posted 31 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Executive Summary
Aims and Hypotheses of the Study:
The aim of the study will be to evaluate the safety, effectiveness and early outcome of the StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric patients. The study will test a hypothesis that the StomaphyX procedure will be effective in promoting the loss of regained weight, reducing the risk for comorbidities and improving patients' quality of life.
Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20
Inclusion Criteria:
18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss.
Exclusion Criteria:
Esophageal stricture, or any anatomic conditions that preclude passage of transoral endoluminal instruments, has another causal factor for weight regain other than stoma or pouch dilatation, portal hypertension, coagulation disorders or chronic use of anticoagulants, any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient.
Intervention Treatment: Creation of multiple full-thickness plications within the gastric pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA)
Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL, uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| StomaphyX Group | Experimental | Device: StomaphyX* Primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. * Patients also demonstrate a weight regain of 15% of excess body weight loss. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70 years
- BMI 35 or greater with one or more comorbidities
- At least 2 years post-Roux-en-Y gastric bypass surgery
- At enrollment, has regained at least 15% of excess body weight loss
- Enlarged Stoma Diameter
Key exclusion criteria (5 listed)
- Esophageal stricture or any anatomic conditions that preclude passage of transoral endoluminal instruments
- Has another causal factor for weight regain other than stoma or pouch dilatation such as non compliant with nutritional and exercise programs
- Portal hypertension
- Coagulation disorders or chronic use of anticoagulants
- Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient
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 |
|---|---|---|
| StomaphyXStomaphyX with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) is a transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications. | Device | StomaphyX Group |
Primary outcome
Primary Outcome: Change in Body Weight
Time frame: At 6 months comparing to baseline weight
Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17024527Thompson CC, Slattery J, Bundga ME, Lautz DB. Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain. Surg Endosc. 2006 Nov;20(11):1744-8. doi: 10.1007/s00464-006-0045-0. Epub 2006 Oct 5.
- Background: PubMed 17498516Elder KA, Wolfe BM. Bariatric surgery: a review of procedures and outcomes. Gastroenterology. 2007 May;132(6):2253-71. doi: 10.1053/j.gastro.2007.03.057.
- Background: PubMed 14691697Fernandez AZ Jr, DeMaria EJ, Tichansky DS, Kellum JM, Wolfe LG, Meador J, Sugerman HJ. Experience with over 3,000 open and laparoscopic bariatric procedures: multivariate analysis of factors related to leak and resultant mortality. Surg Endosc. 2004 Feb;18(2):193-7. doi: 10.1007/s00464-003-8926-y. Epub 2003 Dec 29.
- Background: PubMed 11175957Higa KD, Boone KB, Ho T. Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients--what have we learned? Obes Surg. 2000 Dec;10(6):509-13. doi: 10.1381/096089200321593706.
- Background: PubMed 11851201Sugerman HJ. Bariatric surgery for severe obesity. J Assoc Acad Minor Phys. 2001 Jul;12(3):129-36.
- Background: PubMed 15186628Gould JC, Garren MJ, Starling JR. Lessons learned from the first 100 cases in a new minimally invasive bariatric surgery program. Obes Surg. 2004 May;14(5):618-25. doi: 10.1381/096089204323093381.
- Background: PubMed 17909900Higa KD, Boone K, Nimeri A, Tercero F, Jackson A, Khan A. Gastric bypass: increased restriction for poor weight loss. Surg Endosc. 2007 Nov;21(11):1922-3. doi: 10.1007/s00464-007-9540-1. No abstract available.
- Background: PubMed 17498517Kaplan LM, Klein S, Boden G, Brenner DA, Gostout CJ, Lavine JE, Popkin BM, Schirmer BD, Seeley RJ, Yanovski SZ, Cominelli F. Report of the American Gastroenterological Association (AGA) Institute Obesity Task Force. Gastroenterology. 2007 May;132(6):2272-5. doi: 10.1053/j.gastro.2007.03.061. No abstract available.
- Background: PubMed 18438622Overcash WT. Natural orifice surgery (NOS) using StomaphyX for repair of gastric leaks after bariatric revisions. Obes Surg. 2008 Jul;18(7):882-5. doi: 10.1007/s11695-008-9452-8. Epub 2008 Apr 26.
- Background: PubMed 18443855Cadiere GB, Buset M, Muls V, Rajan A, Rosch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Deviere J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9.
- Background: PubMed 18071818Cadiere GB, Rajan A, Germay O, Himpens J. Endoluminal fundoplication by a transoral device for the treatment of GERD: A feasibility study. Surg Endosc. 2008 Feb;22(2):333-42. doi: 10.1007/s00464-007-9618-9. Epub 2007 Dec 11.
- Background: PubMed 17190659Cadiere GB, Rajan A, Rqibate M, Germay O, Dapri G, Himpens J, Gawlicka AK. Endoluminal fundoplication (ELF)--evolution of EsophyX, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol. 2006;15(6):348-55. doi: 10.1080/13645700601040024.
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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 Phase 2 study testing StomaphyX in people with Morbid Obesity, run by University of Alberta at 1 site in Canada.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 2017. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2017). 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?
Primary Outcome: Change in Body Weight (time frame: At 6 months comparing to baseline weight). 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 NCT01025076, which also lists 23 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 10 Mar 2017.