N/A
N=7
Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
Polyps
Bottom Line
View on ClinicalTrials.gov: NCT00553436 ↗Enrolled (actual)
7
Serious AEs
28.6%
Results posted
Mar 2010
Primary outcome: Primary: Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS) — 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tissue Apposition System (TAS) Device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS) |
6 | — |
| SECONDARY Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition. |
6 | — |
| SECONDARY Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition |
6 | — |
Summary
The purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care.
Eligibility Criteria
Inclusion Criteria
- At least 21 years of age;
- Willing to give consent and comply with evaluation and treatment schedule;
- Approved for polypectomy per standard preoperative endoscopic evaluation;
- Established indication for a procedure greater than colonoscopy and colonic polypectomy. This will include polyps not suitable for current practice (snare procedure) endoscopic resection by nature of size or location, in which an intestinal resection, laparoscopic-assisted polypectomy is required;
- Surgical area viewable with laparoscopy.
Exclusion Criteria
- Physical or psychological condition which would impair study participation;
- Unable or unwilling to attend follow-up visits and examinations;
- Concurrent surgical procedure;
- Pregnancy;
- A polyp which appears to be an invasive cancer, even with negative pathology;
- A polyp with biopsies suspicious for invasive cancer;
- Participation in any other investigational device or drug study within 30 days prior to enrollment; or
- Any condition which precludes compliance with the study.
Data sourced from ClinicalTrials.gov (NCT00553436). 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.