N/A
N=40
Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device
Polyp of Colon · Fistula
Bottom Line
View on ClinicalTrials.gov: NCT04925271 ↗Enrolled (actual)
40
Serious AEs
5.0%
Results posted
Jun 2023
Primary outcome: Primary: Time to Closure — 23.3; 18.4 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- X-Tack (Device); Overstitch (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Closure |
23.3; 18.4 | — |
| SECONDARY Incomplete Closure |
2; 3 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- > 18 years of age
- Undergoing closure of a gastrointestinal luminal defect for which a suturing device would be otherwise indicated
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04925271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.