NCT03427957

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Post-Menopausal Bleeding
• Post-Menopausal Endometrial Thickness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-01-30
• Completion: 2020-03-01
• First posted: 2018-02-09
• Last updated: 2020-04-20

Locations

2 sites across 1 country: Italy