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NCT07695558
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
Conditions: Small Bowel Anastomosis
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: GI Windows, Inc.
Summary
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
Inclusion Criteria:
1. \>21 years of age, at the time of informed consent
2. 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
3. Willing and able to comply with the Registry procedures and provide written informed consent to participate in the post market study
Exclusion Criteria:
1. Participant does not provide informed consent to be enrolled and followed in the study
2. Participants for whom medical condition warrants use of device outside of indication for use
3. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period.
Source: ClinicalTrials.gov (NCT07695558). StuddyBuddy aggregates publicly available trial information.