SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression

Sponsor

GI Windows, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05046730

Collaborator

(none)

400

Enrollment

Locations

Arms

14.9

Anticipated Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Retraction of Ileostomy	Device: Ileostomy Reversal using Self Forming Magnets (SFM)	N/A

Detailed Description

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 will be 1:1 propensity score matched through nearest neighbor matching to a historical control cohort of patients who underwent ileostomy reversal using conventional closure techniques. 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. Eligibility criteria will be standardized between the prospective investigational treatment arm and the historical control. Within this analysis, propensity score (PS) matching will be used to reduce bias due to potential differences in key covariates between the prospective and retrospective cohorts.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression: A Study to Evaluate Safety and Effectiveness of Self-Forming Magnet (SFM) Anastomosis Device: A Historically Controlled Propensity Matched Study

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prospective Evaluation of the SFM Device 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) 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.
Active Comparator: Retrospective Chart Review of Historical Controls 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) 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.

Arm

Intervention/Treatment

Experimental: Prospective Evaluation of the SFM Device

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)

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.

Active Comparator: Retrospective Chart Review of Historical Controls

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)

Outcome Measures

Primary Outcome Measures

Achieving anastomosis success [30 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants must be >18 years and <80 years
Participant has a temporary loop ileostomy that was created ≥ 2 months but ≤ 10 months prior to reversal
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

Exclusion Criteria:

Radiological or clinical signs of anastomosis leak, active infection (except uncomplicated urinary tract infection)
Ongoing or prolonged ileus or bowel obstruction from original surgery
Index operation was a total proctocolectomy or palliative stoma
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 dialysi

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colon and Rectal Clinical of Orlando	Orlando	Florida	United States	32806
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766
4	The Mount Sinai Medical Center	New York	New York	United States	10029
5	St Francis Hospital	Roslyn	New York	United States	11576
6	Novant Health Clinical Research	Winston-Salem	North Carolina	United States	27101
7	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
8	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
9	UT Health Science Center at Houston	Houston	Texas	United States	77030
10	The Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

GI Windows, Inc.

Investigators

Principal Investigator: Evangelos Messaris, MD, Ph.D, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GI Windows, Inc.

ClinicalTrials.gov Identifier:

NCT05046730

Other Study ID Numbers:

GIW 21-002

First Posted:

Sep 16, 2021

Last Update Posted:

Mar 18, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of Mar 18, 2022