Postmenopausal BleedingNCT05378152
Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
A study testing Pipelle biopsy catheter in people with Postmenopausal Bleeding and Endometrial Cancer, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
Postmenopausal bleeding (PMB) is the occurrence of vaginal bleeding 12 months following a woman's last menstrual cycle. PMB represents one of the most common reasons for referral to gynaecology services. Approximately 10% of women with PMB will be found to have endometrial cancer. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Bleeding, Endometrial Cancer, Endometrial Hyperplasia
- What is being tested?
- Pipelle biopsy catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteIreland
- Study dates
- 24 Sep 2022to 25 Feb 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal
- Postmenopausal bleeding
- Tolerates hysteroscopy
Who cannot join
- Premenopausal
- Any lesion requiring biopsy at time of hysteroscopy
- Obvious cause of bleeding from the vagina or cervix at time of hysteroscopy
- History of endometrial hyperplasia/cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Pipelle Biopsy of Benefit in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity?
Postmenopausal bleeding (PMB) is the occurrence of vaginal bleeding 12 months following a woman's last menstrual cycle. PMB represents one of the most common reasons for referral to gynaecology services. Approximately 10% of women with PMB will be found to have endometrial cancer. The gold standard of investigation of PMB is ambulatory gynaecology through the outpatient hysteroscopy clinic, which is often combined with Pipelle biopsy for endometrial sampling.
Up to 60% of women that present with PMB will have an atrophic-appearing cavity at hysteroscopy. This provides a challenge in obtaining a histological sample through both dilatation \& curretage (D\&C) and Pipelle biopsy. Often, scant tissue that is insufficient for clinical diagnosis is obtained.
Read more
Pipelle biopsy is associated with patient discomfort. It is also associated with costs related to the purchasing of equipment and the processing of samples in the laboratory to the sum of approximately 30 euro per sample. It is rare that a sample taken from an atrophic cavity will return any clinically meaningful result. A negative hysteroscopy reduces the probability of endometrial cancer to 0.6%.
This study aims to compare patients with PMB and atrophic-appearing cavity that undergo pipelle biopsy to those that do not. Differences in pain scores, cost saving and differences in clinical follow up will be assessed to evaluate the benefit of Pipelle biopsy in patients with PMB and atrophic-appearing cavity.
- Being tested
- Pipelle biopsy catheter, Sham procedure
- Keywords
- Postmenopausal bleeding, Ambulatory gynaecology, Endometrial sampling, Endometrial hyperplasia, Endometrial cancer
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipelle biopsy catheterDevice
A speculum will be inserted into the vagina. A Pipelle biopsy catheter will be inserted through the cervix up to the fundus of the uterus. The internal piston will be withdrawn to create negative pressure. The catheter will be moved back and forth and rotated to collect the biopsy. The catheter will then be removed, followed by the speculum. The sample will be sent to the laboratory for assessment.
Sham procedureDevice
A speculum is inserted into the vagina and then removed
| Study group | Role | What they receive |
|---|---|---|
| Pipelle biopsy | Active comparator | This group will undergo an endometrial biopsy performed using a Pipelle catheter in the usual manner performed according to the physician either with or without a speculum and with or without a tenaculum. Local anaesthetic block may or may not be used as per clinical judgement. Receives: Device: Pipelle biopsy catheter |
| No Pipelle biopsy | Sham comparator | This group will undergo a sham procedure where a speculum is inserted into the vagina and then removed. Receives: Device: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Measured: Immediately before procedure, less than 5 minutes prior to starting hysteroscopy
Pain scores
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Measured: Immediately after procedure, within 1 minute of finishing hysteroscopy
Pain scores
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Measured: Immediately after intervention, within 1 minute of carrying out intervention
Secondary outcomes (2)
Cost saving
Cost saving between the two groups
Measured: 3 months
Changes in follow up
Changes in follow up between groups including the number of repeat OPH assessments, follow up visits, repeat ultrasound scans and other related hospital attendances.,
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start24 Sep 2022
- Primary completion23 Feb 2024
- Study completion25 Feb 2024
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 Postmenopausal 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- The Rotunda Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378152
- Sponsor's protocol ID
- REC-2021-025
- Status last verified
- Apr 2024
- First submitted
- 3 May 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tunney DE, Yambasu DS, Gyawali DI, Gaughan DE, O'Dwyer DV, Harrity DC, Reidy DF, Ahmed DR, Molphy DZ, Asandei D, Salameh DF, Burke DN. Endometrial Biopsy Versus No Endometrial Biopsy with a Normal-Appearing Cavity During In-office Hysteroscopy for Postmenopausal Bleeding: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2025 Oct;32(10):914-920. doi: 10.1016/j.jmig.2025.07.007. Epub 2025 Jul 14.
PubMed 40669559
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pipelle Biopsy of Benefit in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity?
- ClinicalTrials.gov ID
- NCT05378152
- Acronym / sponsor ID
- REC-2021-025
- Keywords
- Postmenopausal bleeding, Ambulatory gynaecology, Endometrial sampling, Endometrial hyperplasia, Endometrial cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- The Rotunda Hospital
- Study start
- 24 Sep 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 18 May 2022 (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.
Postmenopausal bleeding (PMB) is the occurrence of vaginal bleeding 12 months following a woman's last menstrual cycle. PMB represents one of the most common reasons for referral to gynaecology services. Approximately 10% of women with PMB will be found to have endometrial cancer. The gold standard of investigation of PMB is ambulatory gynaecology through the outpatient hysteroscopy clinic, which is often combined with Pipelle biopsy for endometrial sampling.
Up to 60% of women that present with PMB will have an atrophic-appearing cavity at hysteroscopy. This provides a challenge in obtaining a histological sample through both dilatation \& curretage (D\&C) and Pipelle biopsy. Often, scant tissue that is insufficient for clinical diagnosis is obtained.
Pipelle biopsy is associated with patient discomfort. It is also associated with costs related to the purchasing of equipment and the processing of samples in the laboratory to the sum of approximately 30 euro per sample. It is rare that a sample taken from an atrophic cavity will return any clinically meaningful result. A negative hysteroscopy reduces the probability of endometrial cancer to 0.6%.
This study aims to compare patients with PMB and atrophic-appearing cavity that undergo pipelle biopsy to those that do not. Differences in pain scores, cost saving and differences in clinical follow up will be assessed to evaluate the benefit of Pipelle biopsy in patients with PMB and atrophic-appearing cavity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pipelle biopsy | Active comparator | Device: Pipelle biopsy catheterThis group will undergo an endometrial biopsy performed using a Pipelle catheter in the usual manner performed according to the physician either with or without a speculum and with or without a tenaculum. Local anaesthetic block may or may not be used as per clinical judgement. |
| No Pipelle biopsy | Sham comparator | Device: Sham procedureThis group will undergo a sham procedure where a speculum is inserted into the vagina and then removed. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal
- Postmenopausal bleeding
- Tolerates hysteroscopy
Key exclusion criteria (4 listed)
- Premenopausal
- Any lesion requiring biopsy at time of hysteroscopy
- Obvious cause of bleeding from the vagina or cervix at time of hysteroscopy
- History of endometrial hyperplasia/cancer
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 |
|---|---|---|
| Pipelle biopsy catheterA speculum will be inserted into the vagina. A Pipelle biopsy catheter will be inserted through the cervix up to the fundus of the uterus. The internal piston will be withdrawn to create negative pressure. The catheter will be moved back and forth and rotated to collect the biopsy. The catheter will then be removed, followed by the speculum. The sample will be sent to the laboratory for assessment. | Device | Pipelle biopsy |
| Sham procedureA speculum is inserted into the vagina and then removed | Device | No Pipelle biopsy |
Primary outcome
Pain scores
Time frame: Immediately before procedure, less than 5 minutes prior to starting hysteroscopy
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Pain scores
Time frame: Immediately after procedure, within 1 minute of finishing hysteroscopy
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Pain scores
Time frame: Immediately after intervention, within 1 minute of carrying out intervention
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
2 secondary outcomes
Cost saving
Time frame: 3 months
Changes in follow up
Time frame: 3 months
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 23 Apr 2024.
- Derived from this study: PubMed 40669559Tunney DE, Yambasu DS, Gyawali DI, Gaughan DE, O'Dwyer DV, Harrity DC, Reidy DF, Ahmed DR, Molphy DZ, Asandei D, Salameh DF, Burke DN. Endometrial Biopsy Versus No Endometrial Biopsy with a Normal-Appearing Cavity During In-office Hysteroscopy for Postmenopausal Bleeding: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2025 Oct;32(10):914-920. doi: 10.1016/j.jmig.2025.07.007. Epub 2025 Jul 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pipelle biopsy catheter in people with Postmenopausal Bleeding and Endometrial Cancer, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 3 inclusion and 4 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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. Some participants in this study may receive a placebo. 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?
Pain scores (time frame: Immediately before procedure, less than 5 minutes prior to starting hysteroscopy). The study lists 3 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 NCT05378152, 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 23 Apr 2024.