SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression

NATerminatedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

February 1, 2022

Primary Completion Date

October 1, 2023

Study Completion Date

December 30, 2023

Conditions
Retraction of Ileostomy
Interventions
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.

Trial Locations (14)

10029

The Mount Sinai Medical Center, New York

11576

St Francis Hospital, Roslyn

17033

Penn State Milton S. Hershey Medical Center, Hershey

27101

Novant Health Clinical Research, Winston-Salem

32803

Advent Health, Orlando

32806

Colon and Rectal Clinical of Orlando, Orlando

37232

Vanderbilt University Medical Center, Nashville

48197

Trinity Health Michigan Heart, Ypsilanti

49508

Spectrum Health / Ferguson Clinic, Grand Rapids

53226

The Medical College of Wisconsin, Milwaukee

77030

UT Health Science Center at Houston, Houston

02215

Beth Israel Deaconess Medical Center, Boston

01655

University of Massachusetts Medical School, Worcester

03766

Dartmouth Hitchcock Medical Center, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GI Windows, Inc.

INDUSTRY