Endometrial BiopsyPhase 4NCT07513493
Pipelle vs the Curved Aspirator Device
A Phase 4 study testing Curved Tip Aspirator and Pipelle in people with Endometrial Biopsy, run by Jefferson Drapkin at 1 site in United States.
Trial summary
The primary aim of this study is to rigorously compare the efficacy of two commonly used endometrial sampling devices, the Pipelle and the Miltex, these devices are standard of care at Maimonides. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Biopsy
- What is being tested?
- Curved Tip Aspirator and Pipelle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2026to 31 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 95 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients <18- 45 years with risk factors for endometrial cancer requiring endometrial biopsy.
- Patients ≥ 45 -95 years with abnormal uterine bleeding.
- Postmenopausal patients with bleeding or suspected endometrial pathology
Who cannot join
- Any patient who does not meet the inclusion criteria.
- Patients with contraindications to endometrial biopsy, including:
- Pregnancy
- Acute pelvic inflammatory disease
- Acute cervical infection
- Acute vaginal infection
- Cervical cancer
- Lack of patient consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Olivia Sher, 718-283-7962, osher@maimo.org
About this study
Official title: The Conventional Pipelle vs the Curved Aspirator Device: a Randomized Controlled Trial
The primary aim of this study is to rigorously compare the efficacy of two commonly used endometrial sampling devices, the Pipelle and the Miltex, these devices are standard of care at Maimonides. This primary objective is critical, as the ability to accurately reach the uterine cavity is fundamental to obtaining adequate samples for histopathological evaluation, which is crucial for diagnosing endometrial cancer and other uterine pathologies.
Read the detailed description
This is a randomized, single-blinded control trial. In this prospective interventional study, patients requiring endometrial sampling will be enrolled from the outpatient clinic of the obstetrics and gynecology department. Patients enrolled in the trial are already scheduled for an endometrial biopsy. In office, endometrial biopsy is a standard of care to access possible disease of the endometrium. Regardless of enrolling in this study, our target patient's population will receive an endometrial biopsy. Current standard is endometrial biopsies are done with both the pipelle and Milltex device based upon availability in the office. These devices are FDA approved for this purpose. Procedural risks include uterine perforation, infection, bleeding or cramping. Risks are the same for both devices. These risks will be discussed when patients sign the procedural consent as regardless of participation in the study patients will receive an endometrial biopsy. The purpose of the consenting them for the study is to consent to randomize and collect data on these patients. PatiUpon enrollment, patients will be randomly assigned to one of two groups: Group A, which will undergo endometrial sampling using the Pipelle device, and Group B, which will undergo sampling using the Miltex device. Patients will be randomized using the NIH randomization tool that correlates patient number with study arm. The study will be single blinded with patient being blinded to the study arm they are assigned.
During the procedure, if the initial attempt with the assigned device fails, defined as the inability to insert the sampler through the external or internal os after two attempts (determined by passing the external os <6cm), the patient will be offered the alternative device as a salvage procedure.
- Conditions
- Endometrial Biopsy
- Being tested
- Curved Tip Aspirator, Pipelle
- Keywords
- Gynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curved Tip AspiratorDevice
Curved Tip Aspirator; Endomitrial Biopsy Devise
PipelleDevice
Pipelle; Endomitrial Biopsy Devise
| Study group | Role | What they receive |
|---|---|---|
| Pipelle | Active comparator | This arm will receive a biopsy using the pipelle device Receives: Device: Pipelle |
| Curved tip aspirator | Experimental | This arm will receive an endometrial biopsy using the curved tip aspirator. Receives: Device: Curved Tip Aspirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining an adeuate histiopathologic sample
defined as the inability to insert the sampler through the external or internal os after two attempts (determined by passing the external os <6cm)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start2 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial BiopsyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jefferson Drapkin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jefferson Drapkin, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513493
- Sponsor's protocol ID
- Pipelle102
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Our consents opted for data to only be shared for this study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Conventional Pipelle vs the Curved Aspirator Device: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07513493
- Acronym / sponsor ID
- Pipelle102
- Conditions
- Endometrial Biopsy
- Keywords
- Gynecology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Jefferson DrapkinUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 7 Apr 2026 (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.
The primary aim of this study is to rigorously compare the efficacy of two commonly used endometrial sampling devices, the Pipelle and the Miltex, these devices are standard of care at Maimonides. This primary objective is critical, as the ability to accurately reach the uterine cavity is fundamental to obtaining adequate samples for histopathological evaluation, which is crucial for diagnosing endometrial cancer and other uterine pathologies.
Detailed description
This is a randomized, single-blinded control trial. In this prospective interventional study, patients requiring endometrial sampling will be enrolled from the outpatient clinic of the obstetrics and gynecology department. Patients enrolled in the trial are already scheduled for an endometrial biopsy. In office, endometrial biopsy is a standard of care to access possible disease of the endometrium. Regardless of enrolling in this study, our target patient's population will receive an endometrial biopsy. Current standard is endometrial biopsies are done with both the pipelle and Milltex device based upon availability in the office. These devices are FDA approved for this purpose. Procedural risks include uterine perforation, infection, bleeding or cramping. Risks are the same for both devices. These risks will be discussed when patients sign the procedural consent as regardless of participation in the study patients will receive an endometrial biopsy. The purpose of the consenting them for the study is to consent to randomize and collect data on these patients. PatiUpon enrollment, patients will be randomly assigned to one of two groups: Group A, which will undergo endometrial sampling using the Pipelle device, and Group B, which will undergo sampling using the Miltex device. Patients will be randomized using the NIH randomization tool that correlates patient number with study arm. The study will be single blinded with patient being blinded to the study arm they are assigned.
During the procedure, if the initial attempt with the assigned device fails, defined as the inability to insert the sampler through the external or internal os after two attempts (determined by passing the external os <6cm), the patient will be offered the alternative device as a salvage procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pipelle | Active comparator | Device: PipelleThis arm will receive a biopsy using the pipelle device |
| Curved tip aspirator | Experimental | Device: Curved Tip AspiratorThis arm will receive an endometrial biopsy using the curved tip aspirator. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients <18- 45 years with risk factors for endometrial cancer requiring endometrial biopsy.
- Patients ≥ 45 -95 years with abnormal uterine bleeding.
- Postmenopausal patients with bleeding or suspected endometrial pathology
Key exclusion criteria (8 listed)
- Any patient who does not meet the inclusion criteria.
- Patients with contraindications to endometrial biopsy, including:
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 |
|---|---|---|
| Curved Tip AspiratorCurved Tip Aspirator; Endomitrial Biopsy Devise | Device | Curved tip aspirator |
| PipellePipelle; Endomitrial Biopsy Devise | Device | Pipelle |
Primary outcome
Obtaining an adeuate histiopathologic sample
Time frame: 30 minutes
defined as the inability to insert the sampler through the external or internal os after two attempts (determined by passing the external os <6cm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Our consents opted for data to only be shared for this study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Curved Tip Aspirator and Pipelle in people with Endometrial Biopsy, run by Jefferson Drapkin at 1 site in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia OB/GYN research manager (718-283-7962, osher@maimo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtaining an adeuate histiopathologic sample (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.