Colon Neoplasms, Crohn Disease (CD), Obesity & Overweight
Conditions
Keywords
Laparoscopic surgery, Intracorporeal anastomosis, Enterotomy closure, Surgical device, Feasibility study
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.
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.
Interventions
DEVICESEGER 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
Seger Surgical Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single-arm, non-randomized feasibility study in which all participants receive the SEGER device during laparoscopic surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anastomotic leaks | Within 30 days post-surgery | Incidence of anastomotic leaks within 30 days post-surgery, assessed by clinical symptoms, imaging findings, or need for reoperation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | Intraoperative | Proportion of procedures with successful deployment of the SEGER IDEA™ device without intraoperative complications. |
| Incidence of postoperative complications | Within 30 days post-surgery | Incidence of postoperative complications including bleeding, infection, stricture formation, or device-related adverse events. |
| Time to complete enterotomy closure | Intraoperative | Time from device deployment to completion of enterotomy closure. |
| Length of hospital stay | Up to 30 days post-surgery | Number of days from surgery to hospital discharge. |
| Need for additional intraoperative interventions | Intraoperative | Use of additional techniques such as reinforcement suturing or alternative closure methods. |
| Patient recovery outcomes | Within 30 days post-surgery | Time to return to normal diet, bowel function, and physical activity. |
Countries
El Salvador
Contacts
PRINCIPAL_INVESTIGATORFrancisco José Alabi Montoya, MD
Hospital Nacional Zacamil
STUDY_DIRECTORBarry Salky, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed