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RECRUITING
NCT07508592
NA

Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

Sponsor: Seger Surgical Solutions

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.

Official title: A Prospective Study on the Usability and Clinical Outcomes of the SEGER IDEA™ Device for Enterotomy Closure

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-02-17

Completion Date

2026-09-01

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DEVICE

SEGER Device

The SEGER device is an investigational surgical device used during laparoscopic gastrointestinal procedures to facilitate intracorporeal closure of enterotomies and support small bowel anastomosis. The device is applied intraoperatively as part of the surgical workflow.

Locations (1)

Hospital Nacional Zacamil

San Salvador, El Salvador