Trials / Recruiting
RecruitingNCT07120945
Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Medtronic - MITG · Industry
- Sex
- Female
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugo™ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for cancer.
Detailed description
This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).
Conditions
- Uterine Fibroids (UF)
- Menstrual Disorders
- Adenomyosis of Uterus
- Endometriosis
- Uterine Prolapse
- Precancerous/Nonmalignant Condition
- Cervical Cancer
- Endometrial Cancer
- Ovarian Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Robotic Assisted-Surgery (RAS) Hysterectomy | Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system. |
Timeline
- Start date
- 2025-08-28
- Primary completion
- 2026-02-25
- Completion
- 2031-05-01
- First posted
- 2025-08-13
- Last updated
- 2026-03-06
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07120945. Inclusion in this directory is not an endorsement.