Clinical trial NCT05046730: SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retraction of Ileostomy
Lead sponsor: GI Windows, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

1. Participants must be \>18 years
2. Participant has a temporary loop ileostomy that was created ≥ 2 months but ≤ 10 months prior to reversal. NOTE: The inclusion of patients with ileostomy after total colectomy and palliative ileostomy is permitted if the patients have estimated overall survival of greater than 2 years or if the loop ileostomy is resulting in persistent fluid and electrolyte disorders or other significant stoma related complications where closure of the ileostomy is required for patient safety.
3. 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
4. BMI ≤ 40 kg/m2
5. American Society of Anesthesiologist (ASA) score \< IV at time of reversal
6. All cancer patients must have completed chemotherapy ≥2 months prior to ileostomy closure
7. 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:

1. Radiological or clinical signs of anastomosis leak, active infection (except uncomplicated urinary tract infection)
2. Ongoing or prolonged ileus or bowel obstruction from original surgery
3. 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
4. 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
5. Requires/d laparotomy at time of ileostomy closure
6. 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)
7. Decompensated chronic obstructive lung disease
8. Pulmonary embolism or myocardial infarction in the prior 6 months
9. Congenital or acquired anomalies of the gastrointestinal tract, including atresias, stenosis, luminal distortion or malrotation
10. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL at time of reversal
11. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis

Primary outcomes:
measure: Achieving anastomosis success
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Orlando
country: United States
facility: Colon and Rectal Clinical of Orlando
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health / Ferguson Clinic
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health Michigan Heart
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
city: Winston-Salem
country: United States
facility: Novant Health Clinical Research
state: North Carolina
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: UT Health Science Center at Houston
state: Texas
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Evangelos Messaris, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: