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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Small Bowel Anastomosis.
- Who it may be relevant to
- Registry conditions: Small Bowel Anastomosis. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Small Bowel Anastomosis
Small Bowel Anastomosis
Primary outcome measures
- Number of Participants with Successful Anastomosis Creation without the Need for Reoperation [Time frame: 30 Days]
Eligibility criteria
Inclusion criteria
- >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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07695558 · GIW 25-001