Small Bowel AnastomosisNCT07695558
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
A study testing Small Bowel Anastomosis in people with Small Bowel Anastomosis, run by GI Windows, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Small Bowel Anastomosis
- What is being tested?
- Small Bowel Anastomosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Small Bowel Anastomosis
- Being tested
- Small Bowel Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Bowel AnastomosisDevice
Also called Flexagon & Flexagon Plus OTOLoc systems
Small Bowel Anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Duodeno-ileal diversion anastomosis | Other | Small Bowel Anastomosis with Flexagon SFM Device Receives: Device: Small Bowel Anastomosis |
| Jejunum-jejunum & ileal-ileal anastomosos | Other | Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc Receives: Device: Small Bowel Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel AnastomosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GI Windows, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695558
- Sponsor's protocol ID
- GIW 25-001
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07695558
- Acronym / sponsor ID
- GIW 25-001
- Conditions
- Small Bowel Anastomosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duodeno-ileal diversion anastomosis | Other | Device: Small Bowel AnastomosisSmall Bowel Anastomosis with Flexagon SFM Device |
| Jejunum-jejunum & ileal-ileal anastomosos | Other | Device: Small Bowel AnastomosisSmall Bowel Anastomosis with Flexagon SFM Device with OTOLoc |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Bowel AnastomosisAlso: Flexagon & Flexagon Plus OTOLoc systemsSmall Bowel Anastomosis | Device | Duodeno-ileal diversion anastomosis, Jejunum-jejunum & ileal-ileal anastomosos |
Primary outcome
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
Time frame: 30 Days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Small Bowel Anastomosis in people with Small Bowel Anastomosis, run by GI Windows, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pete Lukin (978 761 0183, peter.lukin@giwindows.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.