Gastric Resection
Conditions
Brief summary
This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, Echelon) stapler and the Titan SGS (Standard Bariatrics, Titan). The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.
Interventions
DEVICEgastric tissue resection
human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
Sponsors
Standard Bariatrics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
1\. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80
Exclusion criteria
1. Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.) 2. Gastric lesion recognized during surgery (entire specimen would be sent to pathology) 3. Stomach damaged during extraction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Evaluation | immediately post operative | Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded. |
| Staple Malformation | through study completion, anticipate within 2 months | Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A - Echelon Stapler Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, Echelon) and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment | 17 |
| Arm B - Titan Stapler Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, Titan) and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment | 18 |
| Total | 35 |
Baseline characteristics
| Characteristic | Arm B - Titan Stapler | Total | Arm A - Echelon Stapler |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 35 Participants | 17 Participants |
| Age, Continuous | 46 years | 44 years | 41 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Female | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pressure Evaluation
Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.
Time frame: immediately post operative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A - Echelon Stapler | Pressure Evaluation | 126 mmHg |
| Arm B - Titan Stapler | Pressure Evaluation | 163 mmHg |
Primary
Staple Malformation
Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.
Time frame: through study completion, anticipate within 2 months