SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression

Stopped early · Not applicable

Conditions studied: Retraction of Ileostomy

In brief

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).

Key facts

Study ID

NCT05046730

Run by

GI Windows, Inc.

People needed

128

Starts

2022-02-01

Expected to finish

2023-12-30

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be >18 years
• 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.
• 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

Where it is running

• Advent Health — Orlando, Florida, United States
• Colon and Rectal Clinical of Orlando — Orlando, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Spectrum Health / Ferguson Clinic — Grand Rapids, Michigan, United States
• Trinity Health Michigan Heart — Ypsilanti, Michigan, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• The Mount Sinai Medical Center — New York, New York, United States
• St Francis Hospital — Roslyn, New York, United States
• Novant Health Clinical Research — Winston-Salem, North Carolina, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• UT Health Science Center at Houston — Houston, Texas, United States
• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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