Clinical trials

4

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Condition / disease
Location
Status: Not yet recruiting

Post Market Study of the Flexagon Only System and Flexagon Plus OTOLoc for Creation of Side-to-Side Duodeno-Ileal Diversion & Flexagon Plus OTOLoc Self Forming Magnet (SFM) System for Creation of Side-to-Side Jejunum-Jejunum and Ileal-Ileal Anastomoses

The objective of this study is to confirm the safety and effectiveness of the Flexagon \& Flexagon Plus OTOLoc systems when used to create respective side-to-side anastomosis in participants undergoing laparoscopic / endoscopic small bowel surgery.

Participants needed: 70
Trial details
Age: 22+Biological sex: AllType: InterventionalSponsor: GI Windows, Inc.Updated: Aug 19, 2026
Eligibility criteria

>21 years of age, at the time of informed consent [+2]

Participant does not provide informed consent to be enrolled and followed in the... [+2]

Status: Recruiting

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

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.

Participants needed: 30
Trial details
Age: 22+Biological sex: AllType: InterventionalSponsor: GI Windows, Inc.Updated: Jul 6, 2026Locations: 2
Eligibility criteria

Aged 22 years or older at screening [+6]

Known or suspected allergy to silicone, nickel, titanium or Nitinol [+18]

Status: Recruiting

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

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.

Participants needed: 65
Trial details
Age: 22+Biological sex: AllType: InterventionalSponsor: GI Windows, Inc.Updated: Jul 6, 2026Locations: 2
Eligibility criteria

Aged 22 years or older at screening [+6]

Known or suspected allergy to silicone, nickel, titanium or Nitinol [+19]

Status: Recruiting

Magnet Anastomosis in Patients Undergoing Gastric Surgery

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 gastro-jejunal anastomosis in participants undergoing gastric surgery.

Participants needed: 75
Trial details
Age: 22+Biological sex: AllType: InterventionalSponsor: GI Windows, Inc.Updated: Jul 6, 2026Locations: 2
Eligibility criteria

Aged 22 years or older at screening [+5]

Known or suspected allergy to silicone, nickel, titanium or Nitinol [+17]