Clinical trial · Interventional
Apollo Overstitch, a Treat and Resect Model
Evaluation of a Novel Endoscopic Suturing Device in a Treat and Resect Model
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Benign Tumor | — | UNRESOLVED | — |
| Colon Malignant Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Overstitch Endoscopic Suturing System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopic suturing device
- description
- 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.
- interventionNames
- Device: Overstitch Endoscopic Suturing System
Primary outcomes (2)
- measure
- Successful Suture Approximation With Cinching Device
- timeFrame
- Approximately 1 hour post resection of the colon in surgery
- description
- 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).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available