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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorGI Windows, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

>21 years of age, at the time of informed consent

Indicated for a side-to-side duodeno-ileal diversion, jejunum-jejunum or ileal-ileal anastomosis and no other concomitant surgical procedures (i.e. hiatal hernia repair, ventral hernia repair or gallbladder removal) planned in conjunction with SFM device placement

Willing and able to comply with the Registry procedures and provide written informed consent to participate in the post market study

Disqualifiers

Participant does not provide informed consent to be enrolled and followed in the study

Participants for whom medical condition warrants use of device outside of indication for use

Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period.

Trial design

Treatments tested in this trial

  • Small Bowel Anastomosis

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators