Magnetic Device for Intestinal Anastomosis

(FLOWS Trial)

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

70 Participants Needed

Trial Summary

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.

How is the Flexagon SFM Device with OTOLoc treatment different from other treatments for intestinal anastomosis?

The Flexagon SFM Device with OTOLoc is unique because it uses magnetic compression to create a connection between intestinal sections without the need for staples or sutures, reducing the risk of inflammation and foreign body reactions. The magnetic rings are eventually expelled naturally, making the process less invasive and potentially lowering medical costs. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Erik Wilson, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

I have had high potassium levels, blood clotting issues, or a history of blood clots in my veins or lungs.

Active H. pylori infection

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical applications of magnetic rings in colorectal anastomosis. [2009]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The restoration of esophageal patency in cicatricial strictures by using magnetic elements]. [2016]

3. Germany 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. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[The Development of Anastomat of Digestive Tract Based on the Magnetic Compressive Technique]. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of sutureless anastomosis after ileostomy takedown using the self-forming magnet anastomosis system in a porcine model. [2023]