GYN DisordersNCT05945433
Anovo™ Surgical System - Registry Study
An observational study of GYN Disorders, run by Momentis Surgical at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- GYN Disorders
- What is being tested?
- anovo™ Surgical System
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2023to Jun 2026
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- -none
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
AdventHealth
Celebration, Florida, 34747
Jenni Freed, BSN, 407-303-9989, jenni.freed@adventhealth.com
Erica Stockwell, DO
About this study
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).
Read the detailed description
Specific Aims:
- 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.
- Collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience.
- Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.
- Conditions
- GYN Disorders
- Being tested
- anovo™ Surgical System
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anovo™ Surgical SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Patients undergoing gynecological surgical procedure with the anovo Surgical System | Not described Receives: Device: anovo™ Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate to open or laparoscopic approach
Measured: Procedure
Rate of Unanticipated Adverse Device Effect
Measured: 8 Weeks Follow Up
Secondary outcomes (1)
Surgery time (minutes)
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start28 Jun 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GYN DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Momentis Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945433
- Sponsor's protocol ID
- Momentis2023GYNRegistry
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anovo™ Surgical System - Registry Study
- ClinicalTrials.gov ID
- NCT05945433
- Acronym / sponsor ID
- Momentis2023GYNRegistry
- Conditions
- GYN Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Momentis SurgicalIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Specific Aims:
- 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.
- Collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience.
- Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing gynecological surgical procedure with the anovo Surgical System | – | Device: anovo™ Surgical System |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anovo™ Surgical SystemThe 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. | Device | Patients undergoing gynecological surgical procedure with the anovo Surgical System |
Primary outcome
Conversion rate to open or laparoscopic approach
Time frame: Procedure
Rate of Unanticipated Adverse Device Effect
Time frame: 8 Weeks Follow Up
1 secondary outcome
Surgery time (minutes)
Time frame: Procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GYN Disorders, run by Momentis Surgical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon H Branch (9543033777, sharon.branch@momentissurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate to open or laparoscopic approach (time frame: Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.