Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses

Part of paid clinical trials in Orlando, Florida.

Sponsor
GI Windows, Inc.
Study ID
NCT07276529
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses — DEVICE
    The SFM plus OTOLoc is used to create an immediate flow compression anastomosis for patients undergoing: Right or Left Hemicolectomy, Sigmoidectomy and Low Anterior resection

Study Details

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 creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.

Key Dates

First listed
Dec 11, 2025
Start date
Apr 1, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Flexagon SFM plus OTOLoc for Magnet Colon Anastomosis
    Patients will receive the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side Colorectal Anastomoses in Patients Undergoing Surgical Procedures via endoscopic or laparoscopic delivery methods

Primary Outcome Measure

Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation. [ Time Frame: 30 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Orlando HealthOrlandoFlorida32806
Antonio Caycedo, MD., MSc
[email protected]
407-422-3790
University of Texas Health Science CenterHoustonTexas77030
Erik Askenasy, MD
Erik Askenasy, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orlando, FL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Orlando Health· Orlando, FLUniversity of Texas Health Science Center· Houston, TX

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