Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
Recruiting
N/A
Interventional Study
Colorectal Cancer
Diverticular Diseases
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
- 30 (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 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Aged 22 years or older at screening
2. Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery
3. Able to understand and sign informed consent document
4. American Society of Anesthesiol…
Contacts