Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-02

Study Completion Date

2020-12-16

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.

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ENROLLING_BY_INVITATION PHASE2/PHASE3

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational device

The investigational device will be used for all participants

Group Type EXPERIMENTAL

Titan SGS stapler

Intervention Type DEVICE

Stapler for the longitudinal resection of the stomach

Interventions

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Titan SGS stapler

Stapler for the longitudinal resection of the stomach

Intervention Type DEVICE

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No