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Status unknownNCT02590666Updated Mar 9, 2016

Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers

An interventional study of Bipolar Polypectomy and Mechanical Polypectomy in Endometrial Polyps, sponsored by University of Cagliari. Status unknown. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-09.

Sponsored by University of Cagliari · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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. 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

02

Conditions studied

  • Endometrial Polyps
03

In context

Lead sponsor

University of Cagliari is the lead sponsor of 82 studies on the registry; 17 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • The patient must be informed about the study, and sign the informed consent

Exclusion criteria

Exclusion Criteria:

  • Positive Pap smear test
  • Pregnancy
  • Uterine malignancy
  • Abnormal uterine bleeding
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Bipolar electrode

    Polyps resection with bipolar electrode

    Procedure: Bipolar Polypectomy · Device: Bipolar electrode

  • Active comparator
    Microscissors or graspers

    Polyps resection with microscissors or graspers

    Procedure: Mechanical Polypectomy · Device: Microscissors or graspers

Interventions

  • ProcedureBipolar Polypectomy

    Polyps resection with bipolar electrode

  • ProcedureMechanical Polypectomy

    Polyps resection with microscissors or graspers

  • DeviceBipolar electrode

    Bipolar electrode used to performs polypectomy

  • DeviceMicroscissors or graspers

    Mechanical instruments used to performs polypectomy

06

What researchers measure

Primary outcomes

  1. 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

Other outcomes

  1. Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).

    Time frame: 3 months after resection of the polyp, repeat hysteroscopy to assess recurrence

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02590666
Lead sponsor
University of Cagliari
Responsible party
Stefano Angioni (Associate Professor, University of Cagliari) — Principal investigator
First posted
Oct 29, 2015
Start date
Jun 2016
Primary completion
Jun 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Mar 9, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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