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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07695558
Enrollment
70
Registered
2026-07-10
Start date
2026-08-01
Completion date
2028-06-01
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Bowel Anastomosis

Brief 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.

Detailed description

This is a prospective, multicenter, single-arm post market study of 70 minimum treated patients. Eligible patients requiring side-to-side duodeno-ileal, jejunum-jejunum & ileal-ileal anastomosis will be evaluated for participation in the study.

Interventions

DEVICESmall Bowel Anastomosis

Small Bowel Anastomosis

Sponsors

GI Windows, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation30 DaysThe 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.

Contacts

CONTACTPete Lukin
peter.lukin@giwindows.com978 761 0183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026