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

Post-Menopausal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427957
• Other study ID #: HYGREB-1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 1, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Post-Menopausal Bleeding
• Post-Menopausal Endometrial Thickness

Intervention

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.
• Endometrial biopsy with the hysteroscopic spoon grasper
Hysteroscopic endometrial biopsy performed through the spoon grasper.
• Endometrial biopsy with the hysteroscopic alligator grasper
Hysteroscopic endometrial biopsy performed through the alligator grasper.

Locations

Country	Name	City	State
Italy	University of Catania	Catania
Italy	University of Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the hysteroscopy	Duration of the hysteroscopic procedure, expressed in minutes and seconds.	During the hysteroscopy
Primary	Pain perceived by the patient	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".	During the hysteroscopy
Secondary	Number of attempts	Number of attempts necessary to perform the biopsy	During the hysteroscopy
Secondary	Size of the specimen	Size of the specimen obtained through biopsy, expressed in mm2	During the hysteroscopy
Secondary	Feasibility assessment by the operator	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".	During the hysteroscopy
Secondary	Precision	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".	During the hysteroscopy