Magnet Anastomosis in Patients Undergoing Gastric Surgery

ConditionGastric Anastomosis (Site)

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 gastro-jejunal anastomosis in participants undergoing gastric surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 22 years or older at screening

Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosis 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

Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc
Device
This study will investigate one type of intervention: gastric-jejunal anastomosis creation in subjects undergoing surgical procedures. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into portions of the stomach and the jejunum that are intended to be anastomosed. An OTOLoc device will be deployed into the gastric wall of the stomach to provide access for the deployment of a Flexagon SFM into the stomach. The process is repeated at an intended section of jejunum. 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

75 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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