Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

NCT04347837 | Completed FDA Device

• 1 other identifier: CP-2019-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Investigational device

EXPERIMENTAL

The investigational device will be used for all participants

Device: Titan SGS stapler

Interventions

Titan SGS stapler DEVICE

Stapler for the longitudinal resection of the stomach

Investigational device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Age \< 18 years
• Incarceration
• Prior gastric or foregut surgery (hiatal hernia repair, lap band +/- removal, Nissen fundoplication, gastrostomy tube, greater curve plication, sleeve gastrectomy etc.)
• Diagnosed bleeding disorder (hyper or hypocoagulable state)
• Systemic anticoagulation
• Significant organ system disease
• Stage III CKD or greater
• Liver cirrhosis (any)
• CHG with EF \< 50%
• COPD with O2 dependence
• Uncontrolled diabetes mellitus (A1C \> 10%)
• 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.

Sponsors & Collaborators

• Standard Bariatrics: lead

Study Sites (3)

Kaleida Health Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

WakeMed Bariatric Specialists of North Carolina

Cary, North Carolina, 27511, United States

Location

West Chester Hospital

West Chester, Ohio, 45069, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: July 2, 2020
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

US (3)