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The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cholecystectomy | Experimental | transvaginal cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOTES GEN 1 Toolbox | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Completion | Completion of procedure - transvaginal removal of the gallbladder | Day of Surgery |
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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 |
|---|---|---|
| Eric Hungness, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cholecystectomy | transvaginal cholecystectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cholecystectomy | transvaginal cholecystectomy |
| 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 | Procedure Completion | Completion of procedure - transvaginal removal of the gallbladder | All subjects on whom the procedure was attempted. | Posted | Number | participants | Day of 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 | Cholecystectomy | transvaginal cholecystectomy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
No significant limitations. Small sample size limits inference to a larger population, however it did allow to assess whether the procedure was feasible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheryl Helsinger | Ethicon Endo Surgery, Inc | 513-337-3079 | SHelsing@its.jnj.com |
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| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Herpes zoster infection neurological | Infections and infestations | MedDRA | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Urethral injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
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