Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

NCT07508592 | Completed

• 1 other identifier: SS-Pr-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laparoscopic surgery; Intracorporeal anastomosis; Enterotomy closure; Surgical device; Feasibility study

Outcome Measures

Primary Outcomes (1)

• Incidence of anastomotic leaks

  Incidence of anastomotic leaks within 30 days post-surgery, assessed by clinical symptoms, imaging findings, or need for reoperation.

  Within 30 days post-surgery

Secondary Outcomes (6)

• Technical success rate

  Intraoperative

• Incidence of postoperative complications

  Within 30 days post-surgery

• Time to complete enterotomy closure

  Intraoperative

• Length of hospital stay

  Up to 30 days post-surgery

• Need for additional intraoperative interventions

  Intraoperative

Study Arms (1)

SEGER Device

EXPERIMENTAL

The SEGER device is used intraoperatively during laparoscopic gastrointestinal surgery to facilitate closure of enterotomies and support intracorporeal anastomosis.

Device: SEGER Device

Interventions

SEGER Device 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.

SEGER Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (e.g., age 18-80) who are candidates for
• Laparoscopic ileocolic resection
• Laparoscopic right hemicolectomy
• Elective laparoscopic small bowel-small bowel anastomosis (including jejuno-jejunostomy and ileo-ileal anastomosis) performed as part of gastric bypass surgery (a maximum of 40% of the total enrolled population may consist of bariatric (gastric bypass) cases).
• The surgeon has determined that an intracorporeal anastomosis is appropriate for the case,
• The patient is able to provide informed consent and is willing to participate in the study, and
• The patient has no condition that would preclude safe use of the device.

You may not qualify if:

• Patients in emergency surgery situations (urgent cases where study enrollment and the careful use of a new device are not feasible),
• Patients with extensive intra-abdominal adhesions or anatomical abnormalities that would make intracorporeal anastomosis technically impossible,
• Patients with a known hypersensitivity to titanium or stainless steel (although rare, this relates to staple/anvil materials),
• Pregnant patients.
• Patients with severe uncontrolled coagulopathy or other high-risk medical conditions that, in the judgment of the investigator and surgical team, do not allow for a safe surgical procedure

Sponsors & Collaborators

• Seger Surgical Solutions: lead

Study Sites (1)

Hospital Nacional Zacamil

San Salvador, El Salvador

Location

MeSH Terms

Conditions

Colonic Neoplasms; Crohn Disease; Obesity; Overweight

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco José Alabi Montoya, MD

  Hospital Nacional Zacamil

  PRINCIPAL INVESTIGATOR

• Barry Salky, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, non-randomized feasibility study in which all participants receive the SEGER device during laparoscopic surgery.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: February 17, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 5, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)