Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

Seger Surgical Solutions10 enrolled

Overview

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.

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

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of anastomotic leaks

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

Time frame: Within 30 days post-surgery

Secondary Outcomes

Technical success rate

Proportion of procedures with successful deployment of the SEGER IDEA™ device without intraoperative complications.

Time frame: Intraoperative

Incidence of postoperative complications

Incidence of postoperative complications including bleeding, infection, stricture formation, or device-related adverse events.

Time frame: Within 30 days post-surgery

Time to complete enterotomy closure

Time from device deployment to completion of enterotomy closure.

Time frame: Intraoperative

Length of hospital stay

Number of days from surgery to hospital discharge.

Time frame: Up to 30 days post-surgery

Need for additional intraoperative interventions

Use of additional techniques such as reinforcement suturing or alternative closure methods.

Time frame: Intraoperative

Patient recovery outcomes

Time to return to normal diet, bowel function, and physical activity.

Time frame: Within 30 days post-surgery

Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts