Magnetic Device for Intestinal Anastomosis

(FLOWS Trial)

No longer recruiting at 6 trial locations

Overseen By Peter Lukin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GI Windows, Inc.

Must not be taking: Immunosuppressants, Corticosteroids, others

Disqualifiers: Obesity, Diabetes, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new device called the Flexagon SFM system with OTOLoc, used during small bowel surgery to join parts of the intestine. Suitable candidates for this trial should be planning to undergo laparoscopic small bowel surgery and live within 185 miles of the study center. This research could enhance surgical methods for this type of procedure. As an unphased trial, it offers participants the chance to contribute to advancements in surgical techniques and potentially benefit from cutting-edge medical technology.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on high-dose corticosteroids or other immunosuppressive treatments, you may not be eligible to participate.

What prior data suggests that the Flexagon SFM Device with OTOLoc is safe for small bowel anastomosis?

Research has shown that the Flexagon SFM Device with OTOLoc is safe for use in surgery. A previous study reported no bleeding, leaks, or deaths when using this device, indicating it functioned safely and effectively in connecting parts of the intestine.

These results offer reassurance to those considering participation in a trial using this device for small bowel surgeries. The absence of major issues in earlier studies strongly suggests the device's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Flexagon SFM Device with OTOLoc is unique because it offers a new approach to intestinal anastomosis by using magnets for tissue connection. Traditional methods typically involve sutures or staples, which can be time-consuming and carry a risk of complications like leaks. This magnetic device aims to simplify the procedure and potentially reduce recovery time by providing a secure, consistent connection. Researchers are excited because this could lead to fewer complications and a faster, more reliable healing process for patients undergoing bowel surgeries.

What evidence suggests that the Flexagon SFM Device with OTOLoc is effective for small bowel anastomosis?

Research shows that the Flexagon SFM device with OTOLoc, evaluated in this trial, holds promise for connecting parts of the bowel during surgery. This device uses magnets to join tissues, promoting faster healing with fewer complications compared to traditional stapling methods. In earlier trials, patients who underwent similar procedures with this device experienced positive outcomes, with the bowel connection remaining strong and healing well. The device aims to enhance surgical safety and reduce recovery time. Early findings suggest it could be a reliable choice for bowel surgeries. ^{1 3 4 5 6}

Who Is on the Research Team?

Erik Wilson, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older who need laparoscopic small bowel surgery and can sign a consent form. They must have medical clearance, be non-smokers during the study, live close to the study center, and have an ASA score less than IV.

Inclusion Criteria

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

Exclusion Criteria

Active H. pylori infection

Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician

Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo small bowel anastomosis using the Flexagon SFM system plus OTOLoc

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Flexagon SFM Device with OTOLoc

Trial Overview The Flexagon SFM system plus OTOLoc is being tested for creating connections in the small intestine during laparoscopic surgery. The goal is to see if it's safe and works well compared to standard methods.

How Is the Trial Designed?

Group I: Study Group: Prospective Evaluation of the Flexagon SFM Device with OTOLoc Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

GI Windows, Inc.

Lead Sponsor

Trials

9

Recruited

340+

Published Research Related to This Trial

A novel magnetic anastomosis device was developed that allows for controlled and flexible placement of implants, successfully achieving stable connections in colorectal surgeries with sufficient holding strength to prevent slippage during healing.

The device demonstrated reproducible detachment from the applicator and maintained safe temperature levels during operation, indicating a low risk of patient hazards related to heating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic tool for the endoscopic creation of colon anastomoses-development and feasibility assessment of a novel anastomosis compression implant approach. Steger, J., Zimmermann, A., Wittenberg, T., et al.[2022]

The developed anastomotic apparatus using magnetic rings effectively restores the submucosal intestinal layer in colorectal surgeries, promoting healing through progressive compression and necrosis of intermediate layers.

In a preliminary study of 21 patients, the technique showed promising results with primary intestinal healing in 18 patients, although there were two cases of suture line dehiscence and one postoperative death due to unrelated causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of magnetic rings in colorectal anastomosis. Jansen, A., Brummelkamp, WH., Davies, GA., et al.[2009]

The use of magnetic devices for esophageal anastomosis and the removal of scarring strictures was successfully demonstrated in four clinical cases, highlighting a novel approach to this surgical challenge.

This technique allowed for less traumatic surgery and resulted in stable positive outcomes, suggesting its potential as an effective intervention in esophageal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The restoration of esophageal patency in cicatricial strictures by using magnetic elements]. Bulynin, VI., Steshkin, VI., Bulynin, VV., et al.[2016]

The new anastomat for digestive tract surgeries simplifies the anastomosis process using magnetic rings, making it easier and more feasible for clinical use.

This device is designed to be cost-effective, as its reusable body and replaceable head reduce medical expenses, and the magnetic rings are safely excreted without causing foreign body reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Development of Anastomat of Digestive Tract Based on the Magnetic Compressive Technique]. Zhang, H., Lv, Y., Liu, C., et al.[2018]

The self-forming magnet (SFM) device allows for the creation of small bowel anastomoses without the use of staples or sutures, resulting in less inflammation and scarring compared to traditional methods, as shown in a preclinical study with 14 pigs.

The SFM anastomosis took an average of 17.1 minutes to create, which is longer than stapled anastomoses (10.3 minutes) but shorter than handsewn anastomoses (28.3 minutes), indicating a balance between safety and efficiency in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sutureless anastomosis after ileostomy takedown using the self-forming magnet anastomosis system in a porcine model. Ore, AS., Askenasy, E., Ryou, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06915337

Magnet Anastomosis in Patients Undergoing Gastric Surgery 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 gastro-jejunal ...

2. ctv.veeva.com ctv.veeva.com/study/functional-lumen-opening-with-self-forming-magnetic-anastomosis

Functional Lumen Opening With Self-Forming Magnetic ... 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 ...

3. trialx.com trialx.com/clinical-trials/listings/296348/flexagon-plus-otoloc-colon-anastomosis-in-patients-undergoing-surgery/

Flexagon Plus OTOLoc Colon Anastomosis in Patients ... The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39904790/

Small bowel magnetic compression anastomosis creation ... We sought to compare the safety and efficacy of the GI Windows Flexagon™ and OTOLoc™ technologies against conventional stapling. Methods: A ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf25/K250541.pdf

August 01, 2025 GI Windows, Inc. Yverre Bobay VP ... The Flexagon SFM Plus OTOLoc device is a magnetic compression anastomosis system, which is a surgical device used for the creation of ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K243482.pdf

June 11, 2025 GI Windows Inc. Yverre Bobay Regulatory VP ... There were no cases of anastomotic bleeding, leakage and no deaths. The Flexagon System performed safely and as intended to create patent ...