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NCT Number: NCT03427957

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

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.

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Key information

Conditions

Post-Menopausal Bleeding Post-Menopausal Endometrial Thickness

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Catania, Catania, Italy

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About this study

Diagnostic hysteroscopy is currently the gold standard method to evaluate uterine cavity and tubal ostia, allowing also the visualization of vaginal walls and the cervical canal. Compared to the other available diagnostic techniques, hysteroscopy has the advantage of directly visualization the anatomical area to be investigated and allows to perform biopsy. The possibility of hysteroscopy-guided biopsy sampling is particularly important in order to get histological diagnosis. As recently suggested, the hysteroscopic biopsy of the endometrium has diagnostic accuracy of 90% for post-menopausal endometrial cancer.

Currently, most diagnostic hysteroscopies are performed in outpatient setting, without anesthesia, using modern hysteroscopes with a 1.67 mm working channel. In particular, endometrial biopsy is usually performed through the classic spoon grasper or alligator 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physiologic menopause
  • Vaginal bleeding or endometrial thickness (>5 mm)

Exclusion criteria

  • Hormonal replacement therapies
  • Other known causes of vaginal/cervical bleeding
  • Suspected or known cancer(s)
  • Premature or iatrogenic menopause
  • Uterine cervix stenosis

Treatment and study plan

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

Diagnostic Test

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

Endometrial biopsy with the hysteroscopic spoon grasper

Diagnostic Test

Hysteroscopic endometrial biopsy performed through the spoon grasper.

Endometrial biopsy with the hysteroscopic alligator grasper

Diagnostic Test

Hysteroscopic endometrial biopsy performed through the alligator grasper.

Primary outcomes

  1. Duration of the hysteroscopy

    Time frame: During the hysteroscopy

    Duration of the hysteroscopic procedure, expressed in minutes and seconds.

  2. Pain perceived by the patient

    Time frame: During the hysteroscopy

    Subjective evaluation of the pain perceived by the patient during the procedure, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means "No pain" and 10 "The worst imaginable pain".

Secondary outcomes

  1. Number of attempts

    Time frame: During the hysteroscopy

    Number of attempts necessary to perform the biopsy

  2. Size of the specimen

    Time frame: During the hysteroscopy

    Size of the specimen obtained through biopsy, expressed in mm2

  3. Feasibility assessment by the operator

    Time frame: During the hysteroscopy

    Subjective assessment by the operator of the feasibility of performing the biopsy, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means "No feasible at all" and 10 "The most feasible event I could imagine".

  4. Precision

    Time frame: During the hysteroscopy

    Subjective assessment by the operator of the precision of the biopsy, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means "No precise at all" and 10 "The most precise event I could imagine".

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients With Vaginal Bleeding and/or Endometrial Thickness

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 9, 2018
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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