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Completed

NCT Number: NCT04347837

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.

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Key information

Conditions

Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaleida Health Buffalo General Hospital, Buffalo, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

Titan SGS stapler

Device

Stapler for the longitudinal resection of the stomach

Primary outcomes

  1. Safety of the Titan SGS stapler

    Time frame: 6 weeks

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

  2. Usability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Standard Bariatrics

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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