Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

Surgery Clinical Trial

Official title:

Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347837
• Other study ID #: CP-2019-01
• Status: Completed
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: December 16, 2020

Study information

• Verified date: March 2021
• Source: Standard Bariatrics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 16, 2020
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Titan SGS stapler
Stapler for the longitudinal resection of the stomach

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Standard Bariatrics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the Titan SGS stapler	• Safety will be defined using descriptive statistics for device related adverse events in the study period.	6 weeks
Primary	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