Post-Menopausal BleedingNCT03427957
Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients
A study testing Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws, Endometrial biopsy with the hysteroscopic spoon grasper and Endometrial biopsy with the hysteroscopic alligator grasper in people with Post-Menopausal Bleeding and Post-Menopausal Endometrial Thickness, run by Università degli Studi dell'Insubria at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Post-Menopausal Bleeding, Post-Menopausal Endometrial Thickness
- What is being tested?
- Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws, Endometrial biopsy with the hysteroscopic spoon grasper and Endometrial biopsy with the hysteroscopic alligator grasper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jun 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physiologic menopause
- Vaginal bleeding or endometrial thickness (>5 mm)
Who cannot join
- Hormonal replacement therapies
- Other known causes of vaginal/cervical bleeding
- Suspected or known cancer(s)
- Premature or iatrogenic menopause
- Uterine cervix stenosis
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Catania
Catania, 95100
University of Insubria
Varese, 21100
About this study
Official title: Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients With Vaginal Bleeding and/or Endometrial Thickness
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.
Read the 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.
- Being tested
- Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws, Endometrial biopsy with the hysteroscopic spoon grasper, Endometrial biopsy with the hysteroscopic alligator grasper
- Keywords
- Hysteroscopy, Endometrial biopsy, Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jawsDiagnostic test
Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.
Endometrial biopsy with the hysteroscopic spoon grasperDiagnostic test
Hysteroscopic endometrial biopsy performed through the spoon grasper.
Endometrial biopsy with the hysteroscopic alligator grasperDiagnostic test
Hysteroscopic endometrial biopsy performed through the alligator grasper.
| Study group | Role | What they receive |
|---|---|---|
| New hysteroscopic grasper | Experimental | Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the new grasper with knurled terminal end and cutting jaws. Receives: Diagnostic Test: Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws |
| Classic spoon grasper | Active comparator | Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic spoon grasper. Receives: Diagnostic Test: Endometrial biopsy with the hysteroscopic spoon grasper |
| Classic alligator grasper | Active comparator | Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic alligator grasper. Receives: Diagnostic Test: Endometrial biopsy with the hysteroscopic alligator grasper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the hysteroscopy
Duration of the hysteroscopic procedure, expressed in minutes and seconds.
Measured: During the hysteroscopy
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".
Measured: During the hysteroscopy
Secondary outcomes (4)
Number of attempts
Number of attempts necessary to perform the biopsy
Measured: During the hysteroscopy
Size of the specimen
Size of the specimen obtained through biopsy, expressed in mm2
Measured: During the hysteroscopy
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".
Measured: During the hysteroscopy
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".
Measured: During the hysteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Jun 2019
- Primary completion30 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Menopausal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Ph.D., Principal investigator, Università degli Studi dell'InsubriaSalvatore Giovanni Vitale, M.D., Ph.D., Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427957
- Sponsor's protocol ID
- HYGREB-1
- Status last verified
- Apr 2020
- First submitted
- 19 Jan 2018
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vitale SG, Lagana AS, Caruso S, Garzon S, Vecchio GM, La Rosa VL, Casarin J, Ghezzi F. Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial. Int J Gynaecol Obstet. 2021 Dec;155(3):425-432. doi: 10.1002/ijgo.13669. Epub 2021 Apr 4.
PubMed 33686708
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients With Vaginal Bleeding and/or Endometrial Thickness
- ClinicalTrials.gov ID
- NCT03427957
- Acronym / sponsor ID
- HYGREB-1
- Keywords
- Hysteroscopy, Endometrial biopsy, Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| New hysteroscopic grasper | Experimental | Diagnostic Test: Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jawsPatients allocated in this group will undergo hysteroscopic endometrial biopsy through the new grasper with knurled terminal end and cutting jaws. |
| Classic spoon grasper | Active comparator | Diagnostic Test: Endometrial biopsy with the hysteroscopic spoon grasperPatients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic spoon grasper. |
| Classic alligator grasper | Active comparator | Diagnostic Test: Endometrial biopsy with the hysteroscopic alligator grasperPatients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic alligator grasper. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physiologic menopause
- Vaginal bleeding or endometrial thickness (>5 mm)
Key exclusion criteria (5 listed)
- Hormonal replacement therapies
- Other known causes of vaginal/cervical bleeding
- Suspected or known cancer(s)
- Premature or iatrogenic menopause
- Uterine cervix stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jawsHysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws. | Diagnostic test | New hysteroscopic grasper |
| Endometrial biopsy with the hysteroscopic spoon grasperHysteroscopic endometrial biopsy performed through the spoon grasper. | Diagnostic test | Classic spoon grasper |
| Endometrial biopsy with the hysteroscopic alligator grasperHysteroscopic endometrial biopsy performed through the alligator grasper. | Diagnostic test | Classic alligator grasper |
Primary outcome
Duration of the hysteroscopy
Time frame: During the hysteroscopy
Duration of the hysteroscopic procedure, expressed in minutes and seconds.
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".
4 secondary outcomes
Number of attempts
Time frame: During the hysteroscopy
Size of the specimen
Time frame: During the hysteroscopy
Feasibility assessment by the operator
Time frame: During the hysteroscopy
Precision
Time frame: During the hysteroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Derived from this study: PubMed 33686708Vitale SG, Lagana AS, Caruso S, Garzon S, Vecchio GM, La Rosa VL, Casarin J, Ghezzi F. Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial. Int J Gynaecol Obstet. 2021 Dec;155(3):425-432. doi: 10.1002/ijgo.13669. Epub 2021 Apr 4.
- Individual participant dataSharing planned: No
Related trials for Post-Menopausal Bleeding
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer
Not yet recruitingObservational study
Hysteroscopic Findings With Histopathologic Report of Endometrium in Patients With Postmenopausal Bleeding
Postmenopausal Bleeding
RecruitingObservational study
Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding
Endometrial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Simone Laganà, M.D., Ph.D. principal investigator
Università degli Studi dell'Insubria
Salvatore Giovanni Vitale, M.D., Ph.D. principal investigator
University of Catania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws, Endometrial biopsy with the hysteroscopic spoon grasper and Endometrial biopsy with the hysteroscopic alligator grasper in people with Post-Menopausal Bleeding and Post-Menopausal Endometrial Thickness, run by Università degli Studi dell'Insubria at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the hysteroscopy (time frame: During the hysteroscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.