Anovo™ Surgical System - Registry Study

NCT ID: NCT05945433

Last Updated: 2023-07-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-28

Study Completion Date

2026-06-30

Brief Summary

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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).

Detailed Description

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Specific Aims:

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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GYN Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing gynecological surgical procedure with the anovo Surgical System

anovo™ Surgical System

Intervention Type 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.

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.
* willing to complete post-operative questionnaire

Exclusion Criteria

-none
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Momentis Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AdventHealth

Celebration, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sharon H Branch

Role: CONTACT

9543033777

Matthew McKittrick

Role: CONTACT

6106745544

Facility Contacts

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Jenni Freed, BSN

Role: primary

407-303-9989

Other Identifiers

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Momentis2023GYNRegistry

Identifier Type: -

Identifier Source: org_study_id

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