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The main objective of this trial is to evaluate endoscopic visualization during a laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally through a new device called a Steerable Flex Trocar (SFT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvaginal Sleeve Gastrectomy | Other | Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOTES toolbox | Device | Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Procedures Completed With Successful Endoscopic Visualization. | The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded. | Assessed intra-operatively |
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Inclusion Criteria
Women will be enrolled in this study who:
Exclusion Criteria
Subjects will be excluded from the study for any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Myers, MD, FACS | Riverside Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Hospital | Columbus | Ohio | 43214 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transvaginal Sleeve Gastrectomy | Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transvaginal Sleeve Gastrectomy | Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Proportion of Procedures Completed With Successful Endoscopic Visualization. | The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded. | All subjects on whom the surgery was attempted represent the primary analysis population. | Posted | Number | participants | Assessed intra-operatively |
|
|
Adverse events collected from informed consent date to 12 months post surgery.
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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 | Transvaginal Sleeve Gastrectomy | Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorder postoperative | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal faeces | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Ethicon-Endo Surgery | 1.513.337.3079 | SHelsing@its.jnj.com |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 1 |
| 4 |
| 4 |
| 4 |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Post procedural complications | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |