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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEGER Device | Experimental | The SEGER device is used intraoperatively during laparoscopic gastrointestinal surgery to facilitate closure of enterotomies and support intracorporeal anastomosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Proportion of procedures with successful deployment of the SEGER IDEAâ„¢ device without intraoperative complications. | Intraoperative |
| Incidence of postoperative complications |
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Inclusion Criteria:
Adults (e.g., age 18-80) who are candidates for
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco José Alabi Montoya, MD | Hospital Nacional Zacamil | Principal Investigator |
| Barry Salky, MD | Icahn School of Medicine at Mount Sinai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional Zacamil | San Salvador | El Salvador |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003424 | Crohn Disease |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Single-arm, non-randomized feasibility study in which all participants receive the SEGER device during laparoscopic surgery.
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|
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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |