Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery
Recruiting
N/A
Interventional Study
Colon Anastomosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 65 (estimated)
- Sponsor
- GI Windows, Inc. · Industry
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About This Trial
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Aged 22 years or older at screening
2. Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) with cardiac/medical clearance for surgery
3. Able to understand and sign informed consent documen…
Contacts