Uterine LeiomyomasNCT02520414
Symphion® System In-Office Study
A study testing Symphion® Bipolar Hysteroscopic Tissue Resection System in people with Uterine Leiomyomas and Endometrial Polyps, run by Minerva Surgical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Leiomyomas, Endometrial Polyps
- What is being tested?
- Symphion® Bipolar Hysteroscopic Tissue Resection System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system
- Confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the Protocol guidelines for inclusion
- Subject has signed written Informed Consent
Who cannot join
- Subjects who are pregnant
- Subjects who have an active genital tract infection (as assessed by the physician)
- Subjects who have cervical malignancies
- Subjects who have previously been diagnosed with endometrial cancer
- Subjects who have Type 2 intracavitary myomas
- Type 0 or 1 intracavitary myoma greater than 3.0 cm
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Women's Surgery
Albuquerque, New Mexico, 87106
About this study
Official title: A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment
The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.
Read the detailed description
The purpose is to determine the safety and feasibility of using an intrauterine tissue resection system in the office setting, as well as to expand the national discussion regarding in-office hysteroscopic procedures as it relates to the highest standards of care and cost containment.
- Conditions
- Uterine Leiomyomas, Endometrial Polyps
- Being tested
- Symphion® Bipolar Hysteroscopic Tissue Resection System
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphion® Bipolar Hysteroscopic Tissue Resection SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Symphion® | Experimental | Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. Receives: Device: Symphion® Bipolar Hysteroscopic Tissue Resection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
Absence of device related adverse events, or death.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uterine LeiomyomasStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minerva Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520414
- Sponsor's protocol ID
- U0524
- Status last verified
- Mar 2021
- First submitted
- 6 Nov 2014
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment
- ClinicalTrials.gov ID
- NCT02520414
- Acronym / sponsor ID
- U0524
- Conditions
- Uterine Leiomyomas, Endometrial Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Minerva Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.
Detailed description
The purpose is to determine the safety and feasibility of using an intrauterine tissue resection system in the office setting, as well as to expand the national discussion regarding in-office hysteroscopic procedures as it relates to the highest standards of care and cost containment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symphion® | Experimental | Device: Symphion® Bipolar Hysteroscopic Tissue Resection SystemPatients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system
- Confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the Protocol guidelines for inclusion
- Subject has signed written Informed Consent
Key exclusion criteria (6 listed)
- Subjects who are pregnant
- Subjects who have an active genital tract infection (as assessed by the physician)
- Subjects who have cervical malignancies
- Subjects who have previously been diagnosed with endometrial cancer
- Subjects who have Type 2 intracavitary myomas
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 |
|---|---|---|
| Symphion® Bipolar Hysteroscopic Tissue Resection System | Device | Symphion® |
Primary outcome
Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
Time frame: 2 weeks
Absence of device related adverse events, or death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symphion® Bipolar Hysteroscopic Tissue Resection System in people with Uterine Leiomyomas and Endometrial Polyps, run by Minerva Surgical, Inc. 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 7 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas. (time frame: 2 weeks). 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 26 Mar 2021.