Polyp of ColonNCT04925271
Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device
A study testing X-Tack and Overstitch in people with Polyp of Colon and Fistula, run by Thomas Jefferson University at 1 site in United States.
Trial summary
After removing large polyps from the gastrointestinal tract, gastroenterologists close the new defect with devices to prevent complications like bleeding or the development of a leak. Commonly, this is done with a device called Overstitch, which allows the gastroenterologist to stitch the defect with an endoscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp of Colon, Fistula
- What is being tested?
- X-Tack and Overstitch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 30 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Undergoing closure of a gastrointestinal luminal defect for which a suturing device would be otherwise indicated
Who cannot join
- INR > 2
- Platelets < 150
- Ongoing anticoagulation not meeting ASGE Antithrombotic Guidelines (Acosta RD et al, The Management of Antithrombotic Agents for Patients Undergoing GI Endoscopy, Gastrointest Endosc, 2016; 83(1): 3-16)
- Hemodynamic instability
- Ongoing or anticipated pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
After removing large polyps from the gastrointestinal tract, gastroenterologists close the new defect with devices to prevent complications like bleeding or the development of a leak. Commonly, this is done with a device called Overstitch, which allows the gastroenterologist to stitch the defect with an endoscope. A new device called X-tack has been developed to simplify endoscopic stitching. In this study, the new X-tack device will be compared to Overstitch when closing defects in the gastrointestinal tract. The two devices will be compared to see how long it takes to close a defect, as well as if there are any differences in complications like bleeding or infection.
Read the detailed description
Currently, the community standard is that gastroenterologists who are familiar with Overstitch start using the X-Tack without additional training. However, a hands-on demonstration session with the X-Tack device in a "dry lab" has been conducted with each endoscopist in the trial prior to the study in order to familiarize them with device before enrollment. Each endoscopist has also participated in a "wet lab" using an explant (porcine stomach) to simulate in vivo closure of defects using the X-Tack system. The device operates in a similar fashion compared to previous suturing devices, which are used frequently by all endoscopists involved in this study. On this basis, all endoscopists in the study report comfort and familiarity with the X-Tack system, and the "break-in" period is not anticipated to affect safety or results during the study. The primary study visit will be comprised of the endoscopic procedure at the time of defect closure and a telephone call 48-72 hours later to assess for complications. Patient will be enrolled in the pre-procedure area. If the patient has a pre-procedure visit, they may be notified of their potential for enrollment in the study at that time, though not all patients have a pre-procedure visit in our practice. Patients will be randomized to closure with the X-Tack system versus closure with the Overstitch system prior to their procedure using a centralized computer-generated randomization. Technical success of closure, time of closure, number of sutures required, need for alternative modalities for closure, and any intraprocedural complications (bleeding, perforation) will be recorded. Any patient with possible periprocedural perforation will receive antibiotics at the endoscopist's discretion. At the endoscopist's discretion, the patient may cross over during the procedure to the other group if they believe that their current closure strategy is failing to safely close the defect. Alternate methods of closure (TTS clips, over-the-scope clips) may be used in either group if required by the endoscopist for safe closure of the defect. After the procedure, most patients are observed in the recovery area for 1-2 hours for any signs of complications before they are discharged home.
- Conditions
- Polyp of Colon, Fistula
- Being tested
- X-Tack, Overstitch
- Keywords
- Endoscopic submucosal dissection, Suturing
- Medical subject headings
- Colonic Polyps, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-TackDevice
The mucosal or submucosal defect is closed with X-Tack.
OverstitchDevice
The mucosal or submucosal defect is closed with Overstitch.
| Study group | Role | What they receive |
|---|---|---|
| X-Tack | Experimental | The gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device. Receives: Device: X-Tack |
| Overstitch | Active comparator | The gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device. Receives: Device: Overstitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Closure
The time required to close the defect using the device
Measured: At time of endoscopy
Secondary outcomes (1)
Incomplete Closure
Either crossover to the other study group per endoscopist's discretion, or the need for additional modalities to close the defect such as endoscopic clips
Measured: At time of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
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 (8)Papers the sponsor has linked to this study.
- Other trials for Polyp of ColonStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing closure of a mucosal or submucosal defect in the gastrointestinal tract will be randomized 1:1 to either closure with X-Tack or closure with Overstitch.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Kumar, Thomas Jefferson University
- Investigators
- Anand Kumar, MD MPH, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925271
- Sponsor's protocol ID
- 21D.166
- Status last verified
- Jun 2023
- First submitted
- 31 May 2021
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in any publications from the trial after deidentification (text, tables, figures and appendices) will be made available upon request.
Publications
Kothari ST, Huang RJ, Shaukat A, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Khashab MA, Jamil LH, Jue TL, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Thosani N, Yang J, DeWitt JM, Wani S; ASGE Standards of Practice Committee Chair. ASGE review of adverse events in colonoscopy. Gastrointest Endosc. 2019 Dec;90(6):863-876.e33. doi: 10.1016/j.gie.2019.07.033. Epub 2019 Sep 25.
PubMed 31563271Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
PubMed 30885778Qumseya BJ, Wolfsen C, Wang Y, Othman M, Raimondo M, Bouras E, Wolfsen H, Wallace MB, Woodward T. Factors associated with increased bleeding post-endoscopic mucosal resection. J Dig Dis. 2013 Mar;14(3):140-6. doi: 10.1111/1751-2980.12002.
PubMed 23134152Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503Kantsevoy SV, Bitner M, Mitrakov AA, Thuluvath PJ. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc. 2014 Mar;79(3):503-7. doi: 10.1016/j.gie.2013.10.051. Epub 2013 Dec 12.
PubMed 24332082Zhang QS, Han B, Xu JH, Gao P, Shen YC. Clip closure of defect after endoscopic resection in patients with larger colorectal tumors decreased the adverse events. Gastrointest Endosc. 2015 Nov;82(5):904-9. doi: 10.1016/j.gie.2015.04.005. Epub 2015 May 12.
PubMed 25975527ASGE Standards of Practice Committee; Acosta RD, Abraham NS, Chandrasekhara V, Chathadi KV, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Shergill AK, Wang A, Cash BD, DeWitt JM. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016 Jan;83(1):3-16. doi: 10.1016/j.gie.2015.09.035. Epub 2015 Nov 24. No abstract available.
PubMed 26621548Agnihotri A, Mitsuhashi S, Holmes I, Kamal F, Chiang A, Loren DE, Kowalski TE, Schlachterman A, Kumar AR. Randomized trial of gastric and colorectal endoscopic submucosal dissection defect closure comparing a novel through-the-scope suturing system with an over-the-scope suturing system (with video). Gastrointest Endosc. 2024 Feb;99(2):237-244.e1. doi: 10.1016/j.gie.2023.07.046. Epub 2023 Aug 1.
PubMed 37536633
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device
- ClinicalTrials.gov ID
- NCT04925271
- Acronym / sponsor ID
- 21D.166
- Conditions
- Polyp of Colon, Fistula
- Keywords
- Endoscopic submucosal dissection, Suturing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After removing large polyps from the gastrointestinal tract, gastroenterologists close the new defect with devices to prevent complications like bleeding or the development of a leak. Commonly, this is done with a device called Overstitch, which allows the gastroenterologist to stitch the defect with an endoscope. A new device called X-tack has been developed to simplify endoscopic stitching. In this study, the new X-tack device will be compared to Overstitch when closing defects in the gastrointestinal tract. The two devices will be compared to see how long it takes to close a defect, as well as if there are any differences in complications like bleeding or infection.
Detailed description
Currently, the community standard is that gastroenterologists who are familiar with Overstitch start using the X-Tack without additional training. However, a hands-on demonstration session with the X-Tack device in a "dry lab" has been conducted with each endoscopist in the trial prior to the study in order to familiarize them with device before enrollment. Each endoscopist has also participated in a "wet lab" using an explant (porcine stomach) to simulate in vivo closure of defects using the X-Tack system. The device operates in a similar fashion compared to previous suturing devices, which are used frequently by all endoscopists involved in this study. On this basis, all endoscopists in the study report comfort and familiarity with the X-Tack system, and the "break-in" period is not anticipated to affect safety or results during the study. The primary study visit will be comprised of the endoscopic procedure at the time of defect closure and a telephone call 48-72 hours later to assess for complications. Patient will be enrolled in the pre-procedure area. If the patient has a pre-procedure visit, they may be notified of their potential for enrollment in the study at that time, though not all patients have a pre-procedure visit in our practice. Patients will be randomized to closure with the X-Tack system versus closure with the Overstitch system prior to their procedure using a centralized computer-generated randomization. Technical success of closure, time of closure, number of sutures required, need for alternative modalities for closure, and any intraprocedural complications (bleeding, perforation) will be recorded. Any patient with possible periprocedural perforation will receive antibiotics at the endoscopist's discretion. At the endoscopist's discretion, the patient may cross over during the procedure to the other group if they believe that their current closure strategy is failing to safely close the defect. Alternate methods of closure (TTS clips, over-the-scope clips) may be used in either group if required by the endoscopist for safe closure of the defect. After the procedure, most patients are observed in the recovery area for 1-2 hours for any signs of complications before they are discharged home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients undergoing closure of a mucosal or submucosal defect in the gastrointestinal tract will be randomized 1:1 to either closure with X-Tack or closure with Overstitch.
| Arm | Type | Receives |
|---|---|---|
| X-Tack | Experimental | Device: X-TackThe gastrointestinal tract mucosal or submucosal defect is closed using the X-Tack device. |
| Overstitch | Active comparator | Device: OverstitchThe gastrointestinal tract mucosal or submucosal defect is closed using the Overstitch device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years of age
- Undergoing closure of a gastrointestinal luminal defect for which a suturing device would be otherwise indicated
Key exclusion criteria (5 listed)
- INR > 2
- Platelets < 150
- Ongoing anticoagulation not meeting ASGE Antithrombotic Guidelines (Acosta RD et al, The Management of Antithrombotic Agents for Patients Undergoing GI Endoscopy, Gastrointest Endosc, 2016; 83(1): 3-16)
- Hemodynamic instability
- Ongoing or anticipated pregnancy
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 |
|---|---|---|
| X-TackThe mucosal or submucosal defect is closed with X-Tack. | Device | X-Tack |
| OverstitchThe mucosal or submucosal defect is closed with Overstitch. | Device | Overstitch |
Primary outcome
Time to Closure
Time frame: At time of endoscopy
The time required to close the defect using the device
1 secondary outcome
Incomplete Closure
Time frame: At time of endoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31563271Kothari ST, Huang RJ, Shaukat A, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Khashab MA, Jamil LH, Jue TL, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Thosani N, Yang J, DeWitt JM, Wani S; ASGE Standards of Practice Committee Chair. ASGE review of adverse events in colonoscopy. Gastrointest Endosc. 2019 Dec;90(6):863-876.e33. doi: 10.1016/j.gie.2019.07.033. Epub 2019 Sep 25.
- Background: PubMed 30885778Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
- Background: PubMed 23134152Qumseya BJ, Wolfsen C, Wang Y, Othman M, Raimondo M, Bouras E, Wolfsen H, Wallace MB, Woodward T. Factors associated with increased bleeding post-endoscopic mucosal resection. J Dig Dis. 2013 Mar;14(3):140-6. doi: 10.1111/1751-2980.12002.
- Background: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Background: PubMed 24332082Kantsevoy SV, Bitner M, Mitrakov AA, Thuluvath PJ. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc. 2014 Mar;79(3):503-7. doi: 10.1016/j.gie.2013.10.051. Epub 2013 Dec 12.
- Background: PubMed 25975527Zhang QS, Han B, Xu JH, Gao P, Shen YC. Clip closure of defect after endoscopic resection in patients with larger colorectal tumors decreased the adverse events. Gastrointest Endosc. 2015 Nov;82(5):904-9. doi: 10.1016/j.gie.2015.04.005. Epub 2015 May 12.
- Background: PubMed 26621548ASGE Standards of Practice Committee; Acosta RD, Abraham NS, Chandrasekhara V, Chathadi KV, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Shergill AK, Wang A, Cash BD, DeWitt JM. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016 Jan;83(1):3-16. doi: 10.1016/j.gie.2015.09.035. Epub 2015 Nov 24. No abstract available.
- Derived from this study: PubMed 37536633Agnihotri A, Mitsuhashi S, Holmes I, Kamal F, Chiang A, Loren DE, Kowalski TE, Schlachterman A, Kumar AR. Randomized trial of gastric and colorectal endoscopic submucosal dissection defect closure comparing a novel through-the-scope suturing system with an over-the-scope suturing system (with video). Gastrointest Endosc. 2024 Feb;99(2):237-244.e1. doi: 10.1016/j.gie.2023.07.046. Epub 2023 Aug 1.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in any publications from the trial after deidentification (text, tables, figures and appendices) will be made available upon request.
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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.
Anand Kumar, MD MPH principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-Tack and Overstitch in people with Polyp of Colon and Fistula, run by Thomas Jefferson University 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 2 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 28 Jun 2023. 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 28 Jun 2023). 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?
Time to Closure (time frame: At time of endoscopy). 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 NCT04925271, which also lists 8 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 28 Jun 2023.