Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery (SEGER-FIH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopy-assisted Surgery; Anastomosis, Surgical; Gastrointestinal Surgical Procedures; Enterotomy
• Intervention / Treatment: Device: SEGER Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tal Lavi, Ph.D.; Phone Number: +972527465388; Email: talnewmail@gmail.com
• Study Contact Backup: Name: Jeniffer Bonilla, B.Sc.; Phone Number: +50370983254; Email: jeadrobo13@gmail.com

Study Locations

• El Salvador
  • San Salvador, El Salvador
    • Recruiting
    • Hospital Nacional Zacamil
    • Contact: Alfredo Brito, MD; Phone Number: +503 7854 4546; Email: alfredopinedabrito@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).
2. The surgeon has determined that an intracorporeal anastomosis is appropriate for the case,
3. The patient is able to provide informed consent and is willing to participate in the study, and
4. The patient has no condition that would preclude safe use of the device.

Exclusion Criteria:

1. Patients in emergency surgery situations (urgent cases where study enrollment and the careful use of a new device are not feasible),
2. Patients with extensive intra-abdominal adhesions or anatomical abnormalities that would make intracorporeal anastomosis technically impossible,
3. Patients with a known hypersensitivity to titanium or stainless steel (although rare, this relates to staple/anvil materials),
4. Pregnant patients.
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEGER Device; The SEGER device is used intraoperatively during laparoscopic gastrointestinal surgery to facilitate closure of enterotomies and support intracorporeal anastomosis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Proportion of procedures with successful deployment of the SEGER IDEA™ device without intraoperative complications.	Intraoperative
Incidence of postoperative complications	Incidence of postoperative complications including bleeding, infection, stricture formation, or device-related adverse events.	Within 30 days post-surgery
Time to complete enterotomy closure	Time from device deployment to completion of enterotomy closure.	Intraoperative
Length of hospital stay	Number of days from surgery to hospital discharge.	Up to 30 days post-surgery
Need for additional intraoperative interventions	Use of additional techniques such as reinforcement suturing or alternative closure methods.	Intraoperative
Patient recovery outcomes	Time to return to normal diet, bowel function, and physical activity.	Within 30 days post-surgery

Collaborators and Investigators

• Sponsor: Seger Surgical Solutions
• Investigators: Principal Investigator: Francisco José Alabi Montoya, MD, Hospital Nacional Zacamil; Study Director: Barry Salky, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Feasibility study; Surgical device; Intracorporeal anastomosis; Enterotomy closure
• Other Study ID Numbers: SS-Pr-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No