Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

ConditionColon Anastomosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22+

SponsorGI Windows, Inc.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 22 years or older at screening

Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) with cardiac/medical clearance for surgery

Able to understand and sign informed consent document

American Society of Anesthesiologists (ASA) score < IV at time of procedure

Disqualifiers

Known or suspected allergy to silicone, nickel, titanium or Nitinol

BMI > 55 kg/m2

Uncontrolled diabetes (defined as HbA1c >10%)

Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet

Trial design

Design model

Single group

Treatments tested in this trial

Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc
Device
This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of colon. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed.

Treatment groups

65 Participants

are divided into 1 treatment group

Group A: Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLocExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of Participants with Successful Anastomosis Creation without the Need for Reoperation

The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.

Time frame

30 Days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GI Windows, Inc.

Lead sponsor

Source ClinicalTrials.gov

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