Clinical Trial

Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

Study acronym: SEGER-FIH
Completed
View on ClinicalTrials.gov →
Summary
This is a first-in-human feasibility study designed to evaluate the safety and performance of the SEGER device in patients undergoing elective laparoscopic gastrointestinal surgery requiring intracorporeal anastomosis. The study will include patients undergoing procedures such as small bowel-small bowel and colorectal anastomoses. The SEGER device is intended to facilitate closure of enterotomies and support intracorporeal anastomosis during minimally invasive surgery. The primary objective of the study is to assess the safety of the device and its performance during surgery. Secondary objectives include evaluation of technical success, intraoperative usability, and early postoperative outcomes.
Protocol Amendment History 3 changes
critical Trial completed 2026-06-30
notable Primary completion moved earlier: 2026-08-01 -> 2026-06-01 2026-06-30
minor Completion moved earlier: 2026-09-01 -> 2026-06-05 2026-06-30
Trial Details
NCT Number NCT07508592
Lead Sponsor Seger Surgical Solutions
Conditions Colon Neoplasms, Crohn Disease (CD), Obesity & Overweight
Enrollment 10 participants
Start Date 2026-02-17
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-29