Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

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 Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Titan SGS stapler

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Kaleida Health Buffalo General Hospital
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • WakeMed Bariatric Specialists of North Carolina
  • Ohio
    • West Chester, Ohio, United States, 45069
      • West Chester Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Standard Bariatrics

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): December 16, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CP-2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes