Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-06-28
2026-06-30
Brief Summary
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Detailed Description
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1. To collect RWD from surgeons with varying experience and expertise on their learning curve and time to achieve competency, and as such assess the success of the Skills Development Pathway.
2. Collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience.
3. Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients undergoing gynecological surgical procedure with the anovo Surgical System
anovo™ Surgical System
The anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.
Interventions
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anovo™ Surgical System
The anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.
Eligibility Criteria
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Inclusion Criteria
* willing to complete post-operative questionnaire
Exclusion Criteria
FEMALE
Yes
Sponsors
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Momentis Surgical
INDUSTRY
Responsible Party
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Locations
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AdventHealth
Celebration, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Momentis2023GYNRegistry
Identifier Type: -
Identifier Source: org_study_id
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