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Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients

NCT03427957 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-04-20

No results posted yet for this study

Summary

Hysteroscopic endometrial biopsy is usually performed through the classic spoon grasper. Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was designed, in order to improve feasibility of the procedure, reduce its duration and the discomfort for the patients.

This study aims to compare the outcomes of the three hysteroscopic graspers for endometrial biopsy in post-menopausal patients.

Conditions

  • Post-Menopausal Bleeding
  • Post-Menopausal Endometrial Thickness

Interventions

DIAGNOSTIC_TEST

Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws

Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.

DIAGNOSTIC_TEST

Endometrial biopsy with the hysteroscopic spoon grasper

Hysteroscopic endometrial biopsy performed through the spoon grasper.

DIAGNOSTIC_TEST

Endometrial biopsy with the hysteroscopic alligator grasper

Hysteroscopic endometrial biopsy performed through the alligator grasper.

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Antonio Simone Laganà, M.D., Ph.D. · Università degli Studi dell'Insubria

  • Salvatore Giovanni Vitale, M.D., Ph.D. · University of Catania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-01-30
Completion
2020-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03427957 on ClinicalTrials.gov