Flexagon SFM + OTOLoc for Colorectal Cancer

(Colonic Trial)

Overseen By Jessica Musiak, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GI Windows, Inc.

Must not be taking: Immunosuppressants, Corticosteroids, others

Disqualifiers: Uncontrolled diabetes, Renal disease, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment method for individuals undergoing colon surgery due to colorectal cancer. It tests the safety and effectiveness of a special device used to connect parts of the colon during surgery. The treatment involves a magnet system called Flexagon SFM (Self Forming Magnet) plus OTOLoc. Individuals who completed chemotherapy at least two months ago and require specific types of colon surgeries may qualify for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical advancements.

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 immunosuppressive therapy or high-dose corticosteroids, you may not be eligible to participate.

What prior data suggests that the Flexagon SFM system plus OTOLoc is safe for colorectal anastomosis?

Research has shown that the Flexagon Self Forming Magnet Anastomosis with OTOLoc is safe for surgical use. A previous study reported no bleeding, leaks, or deaths after using this device, suggesting it is well-tolerated by patients. Designed to connect parts of the colon during surgery, the device proved effective without causing serious complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc treatment because it offers a novel approach to creating connections between sections of the intestine after surgery. Unlike traditional methods that rely on sutures or staples, this treatment uses self-forming magnets to create anastomoses, potentially making the process faster and less invasive. The use of endoscopic or laparoscopic delivery methods also means it might reduce recovery time and surgical complications compared to open surgery. This innovative approach aims to improve outcomes for colorectal cancer surgeries, offering a promising alternative to conventional techniques.

What evidence suggests that the Flexagon SFM plus OTOLoc is effective for colorectal cancer?

Research has shown that the Flexagon Self Forming Magnet (SFM) system, combined with OTOLoc, holds promise for connecting parts of the colon during surgery. In this trial, participants will receive the Flexagon SFM plus OTOLoc for creating side-to-side ileo-colic, colo-colonic, and side-to-side or end-to-side colorectal anastomoses. Studies have demonstrated that this method can safely and effectively join different sections of the bowel, such as the ileo-colic and colo-colonic areas. The magnetic device creates strong, stable connections without requiring additional surgeries. Previous research suggests that this approach can reduce complications and improve recovery after surgery. Overall, the Flexagon SFM plus OTOLoc may make bowel surgeries safer and more successful. ^{1 2 4 5 6}

Who Is on the Research Team?

Erik Wilson, MD

Principal Investigator

Chief Medical Officer

Are You a Good Fit for This Trial?

This trial is for individuals undergoing colon surgery due to conditions like colorectal cancer or diverticulosis bleeding. Participants must be suitable for the surgical procedure involving the Flexagon SFM system and OTOLoc.

Inclusion Criteria

I am 22 years old or older.

Able to understand and sign informed consent document

American Society of Anesthesiologists (ASA) score < IV at time of procedure

Exclusion Criteria

Known or suspected allergy to silicone, nickel, titanium or Nitinol

BMI > 55 kg/m2

Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Roll-In (Training) Cohort

A roll-in phase for centers without previous experience with the SFM device, enrolling a maximum of 3 participants

Not specified

Primary Analysis Cohort

Participants undergo side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses with the Flexagon 25mm SFM system plus OTOLoc

Surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Visits at Discharge, Day 7, Day 30, and Day 60

What Are the Treatments Tested in This Trial?

Interventions

• Flexagon Self Forming Magnet Anastomosis Plus OTOLoc

Trial Overview

The safety and effectiveness of a new method using Flexagon Self Forming Magnet Anastomosis plus OTOLoc are being tested to create connections between parts of the colon in patients during surgery.

How Is the Trial Designed?

Group I: Flexagon SFM plus OTOLoc for Magnet Colon Anastomosis Experimental Treatment 1 Intervention

Patients will receive the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side Colorectal Anastomoses in Patients Undergoing Surgical Procedures via endoscopic or laparoscopic delivery methods

Who Is Running the Clinical Trial?

GI Windows, Inc.

Lead Sponsor

Trials

9

Recruited

340+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07276529

Initial Safety of SFM Plus OTOLoc for Creating Side-to- ...

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06915818

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 create a Ileo-colic and ...

3.

withpower.com

withpower.com/trial/phase-small-bowel-anastomosis-6-2024-a28fd

Magnetic Device for Intestinal Anastomosis (FLOWS 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 ...

4.

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 ...

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06915818/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 ...

6.

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 create a ...