Anovo™ Surgical System - Registry Study

Part of paid clinical trials in Celebration, Florida.

Sponsor
Momentis Surgical
Study ID
NCT05945433
Status
Recruiting
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Conditions

  • GYN Disorders

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • anovo™ Surgical System — DEVICE
    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.

Study Details

To collect Real-World Data (RWD) on the ongoing safety and effectiveness of the anovo Surgical system in transvaginal gynecological laparoscopic surgical procedures and to obtain information on the impact of the anovo Skills Development Pathway on user behavior and performance (where performance is measured by the learning curve of the surgeons and procedure outcomes).

Key Dates

Start date
Jun 28, 2023
Status verified
Jul 2023
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Patients undergoing gynecological surgical procedure with the anovo Surgical System

Primary Outcome Measure

Conversion rate to open or laparoscopic approach [ Time Frame: Procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealthCelebrationFlorida34747
Jenni Freed, BSN
[email protected]
407-303-9989
Erica Stockwell, DO (PRINCIPAL_INVESTIGATOR)

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AdventHealth· Celebration, FL