Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

Standard Bariatrics

Status: Completed

Conditions: Surgery

Treatments: Device: Titan SGS stapler

Study type: Interventional

Funder types: Industry

Identifiers

NCT04347837

CP-2019-01

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

62 participants in 1 patient group

Investigational device

Experimental group

Description:

The investigational device will be used for all participants

Treatment:

Device: Titan SGS stapler