MedTrace Logo

Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

NCT07508592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-29

No results posted yet for this study

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.

Conditions

  • Colon Neoplasms
  • Crohn Disease (CD)
  • Obesity & Overweight

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.

Sponsors & Collaborators

  • Seger Surgical Solutions

    lead INDUSTRY

Principal Investigators

  • Francisco José Alabi Montoya, MD · Hospital Nacional Zacamil

  • Barry Salky, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-17
Primary Completion
2026-06-01
Completion
2026-06-05

Countries

  • El Salvador

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07508592 on ClinicalTrials.gov