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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device | Experimental | The investigational device will be used for all participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titan SGS stapler | Device | Stapler for the longitudinal resection of the stomach |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaleida Health Buffalo General Hospital | Buffalo | New York | 14203 | United States | ||
| WakeMed Bariatric Specialists of North Carolina |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 3, 2021 | Jul 22, 2021 | 5 | ||
| Aug 4, 2021 |
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| Cary |
| North Carolina |
| 27511 |
| United States |
| West Chester Hospital | West Chester | Ohio | 45069 | United States |
| Aug 25, 2021 |
| 6 |