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The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugoâ„¢ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for cancer.
This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-Assisted Surgery (RAS) Hysterectomy Procedures | Experimental | Patients indicated for Robotic-Assisted Surgery (RAS) for hysterectomy procedures (radical, modified radical, or total hysterectomy), inclusive of subjects being treated for malignancies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Assisted-Surgery (RAS) Hysterectomy | Device | Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugoâ„¢ RAS system. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical success rate | Surgical success rate is the procedure utilizing Hugoâ„¢ as outlined in the preoperatively defined surgical plan without conversion to an alternative robotic-assisted system, laparoscopy, or open surgery. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Time from skin incision to skin closure | Intraoperative |
| Hospital length of stay | Hospital length of stay from the date of the procedure to discharge |
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Inclusion Criteria:
Exclusion Criteria:
Patient for whom minimally invasive surgery is contraindicated as determined by the Investigator.
Patients with comorbidities or medical characteristics which would preclude the surgical procedure in the opinion of the Investigator.
Patients with an estimated life expectancy of less than 6 months as determined by Investigator
Patients diagnosed with a bleeding disorder and/or who cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
Patients who are pregnant at the time of the surgical procedure.
Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity).
Patients who have participated or are currently participating in an investigational drug or in a device research study that may interfere with this study in the opinion of the Investigator.
Patients with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia at physicians' discretion.
Patients with a pre-surgical diagnosis of recurring cancer and gross metastatic conditions are excluded.
I. For cervical cancer, only patients with Stages 1a1, 1a2, 1b1, may be included, and within these stages, II. Eligibility is further restricted to those with Stage IB1 tumors less than 2 cm (on MRI) and less than 10 mm stromal invasion on excisional biopsy, or less than 50% cervical stromal invasion (on MRI).
III. All other cervical cancer stages are excluded from the study.
Patients with disease spread out of the pelvis requiring surgical intervention with surgical expertise outside of the gynecological space, with the exception of para-aortic lymph node dissection, as determined by the investigator.
Patients who have a body mass index (BMI) > 44.1 kg/m2
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| Name | Affiliation | Role |
|---|---|---|
| Emma Rossi, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension St. Vincent's Riverside | Jacksonville | Florida | 32204 | United States | ||
| The University of South Florida |
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| From procedure to discharge, through approximately 30 days |
| Major complication rate | Overall rate of subjects with one or more complication (Clavien-Dindo Grade III or higher) related to study device and/or procedure, from the first incision through 30 days post-procedure. | 30 Days |
| Complication rate | Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher) related to study device and/or procedure, from the first incision through 30 days post-procedure. | 30 Days |
| Rate of intraoperative adverse events | Rate of intraoperative adverse events related to study device and/or procedure from first incision through skin closure. | Intraoperative |
| Rate of readmission | Rate of readmission within 30 days due to device and/or procedure related adverse events. | 30 Days |
| Rate of therapy-specific adverse events | Rate of complications due to the study device and/or procedure. | 3 Months |
| Tampa |
| Florida |
| 33606 |
| United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Allegheny Health Network - West Penn | Pittsburgh | Pennsylvania | 15224 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D008599 | Menstruation Disturbances |
| D062788 | Adenomyosis |
| D004715 | Endometriosis |
| D014596 | Uterine Prolapse |
| D011230 | Precancerous Conditions |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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