Small Bowel AnastomosisFLOWSNCT06454916
Functional Lumen Opening With Self-Forming Magnetic Anastomosis
A study testing Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc in people with Small Bowel Anastomosis, run by GI Windows, Inc. at 7 sites in United States.
Trial summary
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic 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 with Flexagon SFM Device with OTOLoc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged 22 years or older at screening
- Candidate for laparoscopic small bowel surgery requiring small bowel anastomosis with cardiac/medical clearance for surgery
- Able to understand and sign informed consent document
- American Society of Anesthesiologists (ASA) score < IV at time of procedure
- Lives, and intends to remain, within a 185-mile radius of study center for the duration of the study
- Able to refrain from smoking during study follow-up period
Who cannot join
- Known or suspected allergy to silicone, nickel, titanium or Nitinol
- BMI > 55 kg/m2
- Uncontrolled diabetes (defined as HbA1c >10%)
- Congenital or acquired anomalies of the GI tract, including atresia or malrotation
- Diagnosed with obstructed or perforated colon cancer
- Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
Show all 18Show fewer
- Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
- Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
- Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis
- Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
- Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
- Active H. pylori infection
- Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
- Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
- Contraindication to general anesthesia
- Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
- Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
- Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Fresno Community Hospital and Medical Center
Clovis, California, 93611
University of Miami
Coral Gables, Florida, 33146
Duke Regional Hospital
Durham, North Carolina, 27704
Endeavor Health
Evanston, Illinois, 60201
UT Health Houston
Houston, Texas, 77401
Orlando Health
Orlando, Florida, 32806
Seger Bariatrics and Metabolism, LLC
San Antonio, Texas, 78229
About this study
Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Small Bowel Anastomoses in Patients Undergoing Surgical Procedures
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.
Read the detailed description
This is a multicenter, pivotal study in which clinical outcomes will be prospectively evaluated for a minimum of 70 subjects undergoing anastomosis creation using the Flexagon SFM system plus OTOLoc.
- Conditions
- Small Bowel Anastomosis
- Being tested
- Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Bowel Anastomosis with Flexagon SFM Device with OTOLocDevice
This study will investigate one type of intervention: small bowel anastomosis creation in subjects undergoing laparoscopic small bowel surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically into two different sections of small bowel that are intended to be anastomosed. An OTOLoc device will be deployed into the small bowel wall in one section of the small bowel to provide access for the deployment of a Flexagon SFM into that section of bowel. The process is repeated at the second section of bowel. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two sections of bowel until the anastomosis is fully formed.
| Study group | Role | What they receive |
|---|---|---|
| Study Group: Prospective Evaluation of the Flexagon SFM Device with OTOLoc | Experimental | This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for a minimum of 70 subjects undergoing small bowel anastomosis using the Flexagon SFM Device with OTOLoc. Receives: Device: Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc |
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 posted12 Jun 2024
- Study start4 Oct 2024
- Primary completion30 Jun 2025
- Study completion1 Oct 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI Windows, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Wilson, MD, Study chair, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454916
- Sponsor's protocol ID
- GIW 24-001
- Acronym
- FLOWS
- Status last verified
- Nov 2025
- First submitted
- 6 Jun 2024
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Small Bowel Anastomoses in Patients Undergoing Surgical Procedures
- ClinicalTrials.gov ID
- NCT06454916
- Acronym / sponsor ID
- FLOWS / GIW 24-001
- Conditions
- Small Bowel Anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 12 Jun 2024 (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 primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.
Detailed description
This is a multicenter, pivotal study in which clinical outcomes will be prospectively evaluated for a minimum of 70 subjects undergoing anastomosis creation using the Flexagon SFM system plus OTOLoc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group: Prospective Evaluation of the Flexagon SFM Device with OTOLoc | Experimental | Device: Small Bowel Anastomosis with Flexagon SFM Device with OTOLocThis is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for a minimum of 70 subjects undergoing small bowel anastomosis using the 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 (6 listed)
- Aged 22 years or older at screening
- Candidate for laparoscopic small bowel surgery requiring small bowel anastomosis with cardiac/medical clearance for surgery
- Able to understand and sign informed consent document
- American Society of Anesthesiologists (ASA) score < IV at time of procedure
- Lives, and intends to remain, within a 185-mile radius of study center for the duration of the study
Key exclusion criteria (18 listed)
- Known or suspected allergy to silicone, nickel, titanium or Nitinol
- BMI > 55 kg/m2
- Uncontrolled diabetes (defined as HbA1c >10%)
- Congenital or acquired anomalies of the GI tract, including atresia or malrotation
- Diagnosed with obstructed or perforated colon cancer
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 Anastomosis with Flexagon SFM Device with OTOLocThis study will investigate one type of intervention: small bowel anastomosis creation in subjects undergoing laparoscopic small bowel surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically into two different sections of small bowel that are intended to be anastomosed. An OTOLoc device will be deployed into the small bowel wall in one section of the small bowel to provide access for the deployment of a Flexagon SFM into that section of bowel. The process is repeated at the second section of bowel. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two sections of bowel until the anastomosis is fully formed. | Device | Study Group: Prospective Evaluation of the Flexagon SFM Device with OTOLoc |
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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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. This study is not recruiting at the moment.
Erik Wilson, MD study chair
The University of Texas Health Science Center, Houston
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc in people with Small Bowel Anastomosis, run by GI Windows, Inc. at 7 sites in United States.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 13 Nov 2025.