NCT07508592

Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Seger Surgical Solutions · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-arm, 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 be conducted at a single clinical site in El Salvador. Eligible patients are adults undergoing elective laparoscopic procedures involving intracorporeal anastomosis, including but not limited to small bowel-small bowel (e.g., jejuno-jejunal) and colorectal anastomoses. The SEGER device is intended to facilitate closure of enterotomies and support the creation of intracorporeal anastomoses during minimally invasive surgery. The device will be used intraoperatively according to the study protocol and the investigator's clinical judgment. The primary objective of the study is to evaluate the safety of the device, including the incidence of device-related and procedure-related adverse events. Secondary objectives include assessment of device performance, technical success, intraoperative usability, and early postoperative outcomes. Patients will be followed postoperatively according to the study protocol to assess clinical outcomes and recovery. Data collected will include intraoperative parameters, device performance metrics, and postoperative clinical outcomes.

Conditions

• Gastrointestinal Surgical Procedures
• Anastomosis, Surgical
• Enterotomy
• Laparoscopy-assisted Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-17
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: El Salvador