An observational study in GYN Disorders, sponsored by Momentis Surgical. Status unknown at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Momentis Surgical · Observational
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).
Specific Aims:
161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 37 observational studies indexed under Genital Diseases, Female.
Browse Genital Diseases, Female studies →Momentis Surgical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry.
Inclusion Criteria:
Exclusion Criteria:
-none
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 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.
Conversion rate to open or laparoscopic approach
Time frame: Procedure
Rate of Unanticipated Adverse Device Effect
Time frame: 8 Weeks Follow Up
Surgery time (minutes)
Time frame: Procedure
Surgeon Learning Curve (surgery time against number of operations performed, considering frequency of cases and surgery difficulty)
To be reported as a continuous curve (plot per surgeon), and as the mean difference in surgery times between during learning curve and after learning curve stages (stages defined as before the surgeon achieves a steady state surgical time and after the surgeon achieves the steady state)
Time frame: Procedure
Surgeon Safety Curve (cumulative UADEs against number of operations performed)
Time frame: Procedure
User Skills Development Survey
Time frame: Procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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