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.
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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

Peter J Lukin, BS

9787610183

peter.lukin@giwindows.com

CONTACT

Jessica Musiak, BS

617-501-7697

jessica.musiak@giwindows.com

CONTACT