Anovo™ Surgical System - Registry Study
1 other identifier
observational
300
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2023
CompletedFirst Submitted
Initial submission to the registry
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
July 14, 2023
July 1, 2023
2.9 years
June 29, 2023
July 11, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Conversion rate to open or laparoscopic approach
Procedure
Rate of Unanticipated Adverse Device Effect
8 Weeks Follow Up
Secondary Outcomes (1)
Surgery time (minutes)
Procedure
Other Outcomes (3)
Surgeon Learning Curve (surgery time against number of operations performed, considering frequency of cases and surgery difficulty)
Procedure
Surgeon Safety Curve (cumulative UADEs against number of operations performed)
Procedure
User Skills Development Survey
Procedure
Study Arms (1)
Patients undergoing gynecological surgical procedure with the anovo Surgical System
Interventions
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
All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry. To be eligible to participate in the registry, patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.
You may qualify if:
- 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
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AdventHealth
Celebration, Florida, 34747, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 8 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
July 14, 2023
Study Start
June 28, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 14, 2023
Record last verified: 2023-07