CClinicalTrials.gg
Sign In
CompletedNCT04347837Updated Mar 22, 2021

Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

An interventional study of Titan SGS stapler in Surgery, sponsored by Standard Bariatrics. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Standard Bariatrics · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2020, 5 years 9 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
03

In context

Lead sponsor

Standard Bariatrics is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Investigational device

    The investigational device will be used for all participants

    Device: Titan SGS stapler

Interventions

  • DeviceTitan SGS stapler

    Stapler for the longitudinal resection of the stomach

06

What researchers measure

Primary outcomes

  1. Safety of the Titan SGS stapler

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

    Time frame: 6 weeks

  2. 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.

    Time frame: 1 day

07

Study locations

3 sites
  • Kaleida Health Buffalo General Hospital
    Buffalo, New York 14203, United States
  • WakeMed Bariatric Specialists of North Carolina
    Cary, North Carolina 27511, United States
  • West Chester Hospital
    West Chester, Ohio 45069, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04347837
Lead sponsor
Standard Bariatrics
Responsible party
Sponsor
First posted
Apr 15, 2020
Start date
Jul 2, 2020
Primary completion
Dec 16, 2020
Completion
Dec 16, 2020
Last update
Mar 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Standard Bariatrics

Start the discussion