Status:
COMPLETED
Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
Lead Sponsor:
Standard Bariatrics
Conditions:
Surgery
Eligibility:
All Genders
18-65 years
Phase:
NA
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04347837
Start Date
July 2 2020
End Date
December 16 2020
Last Update
March 22 2021
Active Locations (3)
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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