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NCT01307813 · ClinicalTrials.gov registry record · NA
Apollo Overstitch, a Treat and Resect Model
A NA study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT01307813: Completed NA study, sponsored by University Hospitals Cleveland Medical Center.
NCT01307813 is a NA study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01307813, a NA study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. The quality of cinch element effectiveness was graded on a four-point Likert scale (1 = Poor, 2 = Good, 3 = Very Good, 4 = Excellent).
Interventions
- DEVICE Overstitch Endoscopic Suturing System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-11 |
| Phase | NA |
What the finished NCT01307813 record still lists
NCT01307813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Overstitch Endoscopic Suturing System is the first listed.
NCT01307813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01307813 about?
NCT01307813 is a clinical study titled "Apollo Overstitch, a Treat and Resect Model". 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 approximat...
What is the current status of trial NCT01307813?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2011-02. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01307813?
The interventions under investigation include: Overstitch Endoscopic Suturing System (DEVICE).
Who is sponsoring clinical trial NCT01307813?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01307813's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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