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N/A N=4 Other

Apollo Overstitch, a Treat and Resect Model

Colon Malignant Tumor · Colon Benign Tumor

Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Successful Suture Approximation With Cinching Device — 3.57 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Overstitch Endoscopic Suturing System (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University Hospitals Cleveland Medical Center
Primary completion
Nov 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Successful Suture Approximation With Cinching Device
2.66
PRIMARY
Successful Suture Approximation With Cinching Device
2.66

Summary

The Overstitch (Apollo Endosurgery, Austin, Texas) is an FDA cleared product which attaches to a standard double channel endoscope. The Overstitch can place sutures under endoscopic guidance, with the goal of reproducing standard surgical techniques. These would include hemostasis, tissue approximation, anastomosis formation, fixation of intraluminal devices, or repair/closure of mucosal or full thickness defects such as perforations or endoscopic mucosal resection (EMR) sites. Knot tying of the endoscopically placed sutures is provided by an endoscopic cinching device that passes through the channel of the endoscope. This feasibility trial will evaluate the ability of the Apollo suturing device (Overstitch) to endoscopically place sutures into normal mucosa, and then "tie" the sutures with the cinching device. These devices have been utilized effectively in explant, live porcine, and human cadaver colon and stomach models. In this treat and resect model, sutures would be placed in a segment of colon or stomach that is being surgically removed via open or laparoscopic technique for the treatment of benign or malignant disease. The sutures would be placed in a segment of normal mucosa remote to the pathology being surgically treated. In addition, the sutures will be placed under direct observation via laparoscopic or open visualization. After resection of the segment of colon, it will be evaluated grossly for level of suture placement, evidence of perforation, and quality of suture approximation with the cinching device.

Eligibility Criteria

Inclusion Criteria

  • The patient population in this study will be candidates of either sex, over 18' who have an established indication for a surgical procedure requiring resection of a portion of colon distal to the splenic flexure. This will include both benign and malignant diseases.

Exclusion Criteria

  • Any underlying pathology in the determination of investigator that subject cannot undergo scoping
  • Sutures cannot be placed in segment of bowel that will be included in the surgical resection
  • Pregnant women will be excluded from participating in this protocol
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01307813). 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.

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