Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

• Sponsor: Standard Bariatrics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04347837
• Collaborator: (none)
• Enrollment: 62
• Locations: 3
• Arm: 1
• Actual Duration (Months): 5.5
• Patients Per Site: 20.7
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Device: Titan SGS stapler	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
• Actual Study Start Date: Jul 2, 2020
• Actual Primary Completion Date: Dec 16, 2020
• Actual Study Completion Date: Dec 16, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety of the Titan SGS stapler [6 weeks]

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

2. Usability [1 day]

   • 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

7. Stage III CKD or greater

8. Liver cirrhosis (any)

9. CHG with EF < 50%

10. COPD with O2 dependence

11. Uncontrolled diabetes mellitus (A1C > 10%)

12. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaleida Health Buffalo General Hospital	Buffalo	New York	United States	14203
2	WakeMed Bariatric Specialists of North Carolina	Cary	North Carolina	United States	27511
3	West Chester Hospital	West Chester	Ohio	United States	45069

Sponsors and Collaborators

• Standard Bariatrics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Standard Bariatrics
• ClinicalTrials.gov Identifier: NCT04347837
• Other Study ID Numbers: CP-2019-01
• First Posted: Apr 15, 2020
• Last Update Posted: Mar 22, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Mar 22, 2021