Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

Study Overview
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Brief Summary
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The Titan SGS stapler is the first minimally invasive stapler designed for the longitudinal resection of the stomach. This is the first experience using this stapler in humans. The purpose of this study is to demonstrate use of the Titan SGS stapler in creating longitudinal gastric resection. Safety is defined by the absence of device related adverse events in the study period. Usability is evaluated based on surgeon evaluation of the device following each use. This is a open label clinical trial to be conducted at three US sites. Up to 60 participants will be enrolled and will be followed for 6 weeks after surgery.

Official Title
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Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

Conditions
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Surgery

Intervention / Treatment
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* Device: Titan SGS stapler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients age 18 to 65 undergoing a procedure requiring longitudinal gastric resection including: laparoscopic sleeve gastrectomy, laparoscopic gastric wedge resection, laparoscopic duodenal switch/loop duodenal switch. Exclusion Criteria: Age < 18 years Incarceration Prior gastric or foregut surgery (hiatal hernia repair, lap band +/- removal, Nissen fundoplication, gastrostomy tube, greater curve plication, sleeve gastrectomy etc.) Diagnosed bleeding disorder (hyper or hypocoagulable state) Systemic anticoagulation Significant organ system disease Stage III CKD or greater Liver cirrhosis (any) CHG with EF < 50% COPD with O2 dependence Uncontrolled diabetes mellitus (A1C > 10%) Intraoperative surgeon evaluation indicates the subject is not a candidate for longitudinal gastric resection with the Titan Stapler due to anatomic factors such as extensive abdominal adhesions or the device will not fit for the particular application.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device<br>The investigational device will be used for all participants | Device: Titan SGS stapler<br>* Stapler for the longitudinal resection of the stomach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the Titan SGS stapler | • Safety will be defined using descriptive statistics for device related adverse events in the study period. | 6 weeks | 
| Usability | • Usability of the Titan SGS to resect the stomach will be determined by the intraoperative assessment of the surgeon. The surgeon will complete a questionnaire with assessments of the device. | 1 day |