SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression

NCT05046730 | Terminated DMC FDA Device

• 1 other identifier: GIW 21-002
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 14

Brief Summary

The objectives of this study are to determine the safety and effectiveness of the SFM Anastomosis Device when used to create a small bowel anastomosis for patients undergoing ileostomy reversal as compared with a propensity-matched historic control group of patients who underwent ileostomy reversal using a conventional closure technique (sutures or stapler).

Conditions

Retraction of Ileostomy

Outcome Measures

Primary Outcomes (1)

• Achieving anastomosis success

  The primary effectiveness hypothesis is that anastomosis success rate for the SFM device will be non-inferior to the anastomosis success rate observed for the propensity-matched historical control group

  30 days

Study Arms (2)

Prospective Evaluation of the SFM Device

EXPERIMENTAL

This is a multicenter, single-arm study in which clinical outcomes prospectively evaluated for a minimum of 100 subjects undergoing ileostomy reversal using the SFM Anastomosis Device

Device: Ileostomy Reversal using Self Forming Magnets (SFM)

Retrospective Chart Review of Historical Controls

ACTIVE COMPARATOR

In order to have a sufficient pool of retrospective patients for matching, retrospective data will be collected for a minimum of 300 patients. The historical control cohort will be accrued from the same pool of institutions participating in the prospective study.

Device: Ileostomy Reversal using Self Forming Magnets (SFM)

Interventions

Ileostomy Reversal using Self Forming Magnets (SFM) DEVICE

The magnets will be manually deployed into the small intestine during open surgery following creation of a mini or full laparotomy as clinically indicated. Once the desired segment of small bowel is resected, the magnet is inserted through the open ends of each bowel section. Once proper magnet position is confirmed and the bowel ends are approximated, the magnets couple to form the anastomosis.

Prospective Evaluation of the SFM Device; Retrospective Chart Review of Historical Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be \>18 years
• Preoperative clearance with confirmation of anastomotic integrity of the original resection; i.e., absence of active exacerbation of inflammatory disease (as applicable), stricture or leakage at or distal to the diverted colorectal anastomosis via gastrografin enema and/or endoscopy based on physician's discretion
• BMI ≤ 40 kg/m2
• American Society of Anesthesiologist (ASA) score \< IV at time of reversal
• All cancer patients must have completed chemotherapy ≥2 months prior to ileostomy closure
• Subject or authorized representative have been informed of the nature of the study and has provided written informed consent approved by the appropriate local Institutional Review Board (IRB) and agrees to comply with all protocol-specified follow-up appointments

You may not qualify if:

• Radiological or clinical signs of anastomosis leak, active infection (except uncomplicated urinary tract infection)
• Ongoing or prolonged ileus or bowel obstruction from original surgery
• Requires/d additional abdominal surgery (e.g., Major hernia repair, either necessitating mesh and/or abdominal wall reconstruction) after ileostomy or requires/d concurrent abdominal surgery during reversal procedure
• Multiple small bowel obstructions occurring between ileostomy creation and closure requiring a formal abdominal exploration through a midline incision at the time of ileostomy closure or any other participant in whom laparotomy is required at time of ileostomy closure
• Requires/d laparotomy at time of ileostomy closure
• Congestive heart failure with ejection fraction\<35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
• Decompensated chronic obstructive lung disease
• Pulmonary embolism or myocardial infarction in the prior 6 months
• Congenital or acquired anomalies of the gastrointestinal tract, including atresias, stenosis, luminal distortion or malrotation
• Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL at time of reversal
• Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (14)

Advent Health

Orlando, Florida, 32803, United States

Location

Colon and Rectal Clinical of Orlando

Orlando, Florida, 32806, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Spectrum Health / Ferguson Clinic

Grand Rapids, Michigan, 49508, United States

Location

Trinity Health Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

St Francis Hospital

Roslyn, New York, 11576, United States

Location

Novant Health Clinical Research

Winston-Salem, North Carolina, 27101, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Evangelos Messaris, MD, Ph.D

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 16, 2021
• Study Start: February 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 30, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)