Endometrial PolypsNCT02590666
Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
A study testing Bipolar Polypectomy, Mechanical Polypectomy and Bipolar electrode in people with Endometrial Polyps, run by University of Cagliari.
Trial summary
Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Polyps
- What is being tested?
- Bipolar Polypectomy, Mechanical Polypectomy and Bipolar electrode
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2017
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient must be informed about the study, and sign the informed consent
Who cannot join
- Positive Pap smear test
- Pregnancy
- Uterine malignancy
- Abnormal uterine bleeding
About this study
Official title: Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Among Others bipolar systems and microscissors or graspers, both of theme make part of routine clinical practice and are universally accepted.
The aim of the study is to compare the efficacy of bipolar resection energy polypectomy versus microscissors or graspers These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .
Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients
- Conditions
- Endometrial Polyps
- Being tested
- Bipolar Polypectomy, Mechanical Polypectomy, Bipolar electrode, Microscissors or graspers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar PolypectomyProcedure or surgery
Polyps resection with bipolar electrode
Mechanical PolypectomyProcedure or surgery
Polyps resection with microscissors or graspers
Bipolar electrodeDevice
Bipolar electrode used to performs polypectomy
Microscissors or graspersDevice
Mechanical instruments used to performs polypectomy
| Study group | Role | What they receive |
|---|---|---|
| Bipolar electrode | Experimental | Polyps resection with bipolar electrode Receives: Procedure: Bipolar Polypectomy; Device: Bipolar electrode |
| Microscissors or graspers | Active comparator | Polyps resection with microscissors or graspers Receives: Procedure: Mechanical Polypectomy; Device: Microscissors or graspers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the tolerability of polypectomy using a validated visual analogue pain scale
Measured: we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial PolypsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590666
- Sponsor's protocol ID
- PolypectomyCA
- Status last verified
- Mar 2016
- First submitted
- 25 Oct 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
- ClinicalTrials.gov ID
- NCT02590666
- Acronym / sponsor ID
- PolypectomyCA
- Conditions
- Endometrial Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- 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.
Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Among Others bipolar systems and microscissors or graspers, both of theme make part of routine clinical practice and are universally accepted.
The aim of the study is to compare the efficacy of bipolar resection energy polypectomy versus microscissors or graspers These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .
Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar electrode | Experimental | Procedure: Bipolar Polypectomy, Device: Bipolar electrodePolyps resection with bipolar electrode |
| Microscissors or graspers | Active comparator | Procedure: Mechanical Polypectomy, Device: Microscissors or graspersPolyps resection with microscissors or graspers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patient must be informed about the study, and sign the informed consent
Key exclusion criteria (4 listed)
- Positive Pap smear test
- Pregnancy
- Uterine malignancy
- Abnormal uterine bleeding
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 |
|---|---|---|
| Bipolar PolypectomyPolyps resection with bipolar electrode | Procedure or surgery | Bipolar electrode |
| Mechanical PolypectomyPolyps resection with microscissors or graspers | Procedure or surgery | Microscissors or graspers |
| Bipolar electrodeBipolar electrode used to performs polypectomy | Device | Bipolar electrode |
| Microscissors or graspersMechanical instruments used to performs polypectomy | Device | Microscissors or graspers |
Primary outcome
To assess the tolerability of polypectomy using a validated visual analogue pain scale
Time frame: we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar Polypectomy, Mechanical Polypectomy and Bipolar electrode in people with Endometrial Polyps, run by University of Cagliari.
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 1 inclusion and 4 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
To assess the tolerability of polypectomy using a validated visual analogue pain scale (time frame: we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks). 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 9 Mar 2016.