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| Name | Class |
|---|---|
| NeoSurgical Limited | INDUSTRY |
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The purpose of this study is to compare the neoClose abdominal closure to the standard Carter-Thomason closure in a bariatric surgery gastric bypass population.
Both the neoClose abdominal closure to the standard Carter-Thomason closure will be used to close 12 mm camera port sites and 12 mm stapler port sites upon completion of a robotic assisted laparoscopic gastric bypass. The procedure requires a 12 mm port site be placed in the midline approximately 3 cm cephalad to the umbilicus and a second 12mm port site in the right mid abdomen. Port sites will be closed as defined as the inability to palpate a fascial defect and the incision being air tight upon carbon dioxide insufflation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo Close Abdominal Closure | Experimental |
| |
| Carter Thomason Device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo Close Abdominal Closure | Device | Neo Close Abdominal Closure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site | at the time of surgery | |
| Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site | at the time of surgery | |
| Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site | at the time of surgery | |
| Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site | at the time of surgery | |
| Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site | at the time of surgery | |
| Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively | Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam. | immediately post op |
| Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively | Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam. | 1 week |
| Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | day 1 |
| Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shinil Shah, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neo Close Abdominal Closure | Neo Close Abdominal Closure: Neo Close Abdominal Closure |
| FG001 | Carter Thomason Device | Carter Thomason Device: Carter Thomason Device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neo Close Abdominal Closure | Neo Close Abdominal Closure: Neo Close Abdominal Closure |
| BG001 | Carter Thomason Device | Carter Thomason Device: Carter Thomason Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site | Data were not available for 4 in the NeoClose arm and 3 in the Carter Thomason arm. | Posted | Mean | Standard Deviation | number of sutures | at the time of surgery |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neo Close Abdominal Closure | Neo Close Abdominal Closure: Neo Close Abdominal Closure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor | The University of Texas Health Science Center at Houston | (713) 500-7277 | Shinil.K.Shah@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2017 | Jul 15, 2019 | Prot_SAP_000.pdf |
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| Carter Thomason Device |
| Device |
Carter Thomason Device |
|
Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
| 6 weeks |
| Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively | Abdominal ultrasound will be used to detect port site hernia. | 6 weeks |
Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. |
| 1 week |
| Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | 6 weeks |
| Pain at the Stapler Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | day 1 |
| Pain at the Stapler Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | 1 week |
| Pain at the Stapler Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | 6 weeks |
| Pain as Assessed by Number of Participants Who Took Pain Medications | week 1 |
| Pain as Assessed by Number of Participants Who Took Pain Medications | week 6 |
| Hospital Stay Duration | from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site | Data were not available for 5 in the NeoClose arm and 6 in the Carter Thomason arm. | Posted | Mean | Standard Deviation | number of sutures | at the time of surgery |
|
|
|
| Primary | Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site | Data were not available for 1 in the Carter Thomason arm. | Posted | Mean | Standard Deviation | seconds | at the time of surgery |
|
|
|
| Primary | Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site | Data were not available for 3 in the Carter Thomason arm. | Posted | Mean | Standard Deviation | seconds | at the time of surgery |
|
|
|
| Primary | Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site | Data were not available for 12 participants in the NeoClose arm and 16 participants in the Carter Thomason arm. For each participant analyzed, there were needle depth data available for 1, 2, 3, or 4 stitches per participant. | Posted | Mean | Standard Deviation | centimeters | at the time of surgery | stitch | stitch |
|
|
|
| Primary | Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively | Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam. | Posted | Count of Participants | Participants | immediately post op |
|
|
|
| Primary | Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively | Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Primary | Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively | Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Primary | Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively | Abdominal ultrasound will be used to detect port site hernia. | Data were not available for 1 in the Carter Thomason arm. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | Posted | Mean | Standard Deviation | units on a scale | day 1 |
|
|
|
| Secondary | Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | Pain at the Stapler Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | Posted | Mean | Standard Deviation | units on a scale | day 1 |
|
|
|
| Secondary | Pain at the Stapler Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Pain at the Stapler Port Site as Assessed by a Visual Analog Scale | Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | Pain as Assessed by Number of Participants Who Took Pain Medications | Posted | Count of Participants | Participants | week 1 |
|
|
|
| Secondary | Pain as Assessed by Number of Participants Who Took Pain Medications | Posted | Count of Participants | Participants | week 6 |
|
|
|
| Secondary | Hospital Stay Duration | Posted | Mean | Standard Deviation | days | from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days) |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Carter Thomason Device | Carter Thomason Device: Carter Thomason Device | 0 | 35 | 0 | 35 | 0 | 35 |
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