Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

Standard Bariatrics62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

Titan SGS staplerDEVICE

Stapler for the longitudinal resection of the stomach

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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: 1. Age \< 18 years 2. Incarceration 3. Prior gastric or foregut surgery (hiatal hernia repair, lap band +/- removal, Nissen fundoplication, gastrostomy tube, greater curve plication, sleeve gastrectomy etc.) 4. Diagnosed bleeding disorder (hyper or hypocoagulable state) 5. Systemic anticoagulation 6. Significant organ system disease 1. Stage III CKD or greater 2. Liver cirrhosis (any) 3. CHG with EF \< 50% 4. COPD with O2 dependence 5. Uncontrolled diabetes mellitus (A1C \> 10%) 7. 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.

Locations (3)

Kaleida Health Buffalo General Hospital

Buffalo, New York, United States

WakeMed Bariatric Specialists of North Carolina

Cary, North Carolina, United States

West Chester Hospital

West Chester, Ohio, United States

Outcomes

Primary Outcomes

Safety of the Titan SGS stapler

• Safety will be defined using descriptive statistics for device related adverse events in the study period.

Time frame: 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.

Time frame: 1 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.