Gallbladder Disease
Conditions
Keywords
gallbladder disease, cholecystectomy, gallbladder disease indicated for cholecystectomy
Brief summary
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.
Interventions
DEVICENOTES GEN 1 Toolbox
* Articulating Hook Knife * Articulating Snare * Articulating Needle Knife * Articulating Graspers * Articulating Biopsy Forceps * Steerable Flex Trocar with Rotary Access Needle * Flexible Bipolar Hemostasis Forceps * Flexible Maryland Dissector
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women will be enrolled in this study who: 1. Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires; 2. At least 18 years of age; 3. Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy; 4. ASA Classification I or II (Appendix II); 5. Have a negative serum pregnancy test (for women of childbearing potential); and 6. Absence, on visual inspection, of adhesions judged to be a potentially complicating factor in transvaginal access and operation.
Exclusion criteria
Subjects will be excluded from the study for any of the following: 1. BMI \> 35; 2. Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable); 3. Suspicion of gallbladder cancer, tumor, polyps, or mass; 4. Acute cholecystitis or acute pancreatitis; 5. Presence of common bile duct stones; 6. History of cervical or vaginal cancer (or precancerous findings on most recent Pap Test); 7. Pelvic Inflammatory Disease; 8. Evidence of abdominal abscess or mass; 9. Diffuse peritonitis; 10. Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy; 11. Clinical diagnosis of sepsis; 12. History of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis; 13. History of peritoneal or vaginal trauma; 14. Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial; 15. Planned concurrent surgical procedure; 16. Prior or planned major surgical procedure within 30 days before or after study procedure; 17. History of transvaginal surgery; 18. History of (or symptomatic for) abdominal adhesions; 19. Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints; 20. Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; 21. Any contraindication listed in a study device Instructions for Use (IFU) document (if that device may be used in the study procedure); or 22. Any condition which precludes compliance with the study (Investigator discretion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Completion | Day of Surgery | Completion of procedure - transvaginal removal of the gallbladder |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cholecystectomy transvaginal cholecystectomy | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Cholecystectomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age Continuous | 37.7 years STANDARD_DEVIATION 6.26 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Procedure Completion
Completion of procedure - transvaginal removal of the gallbladder
Time frame: Day of Surgery
Population: All subjects on whom the procedure was attempted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transvaginal Cholecystectomy | Procedure Completion | 7 participants |