Abnormal Uterine BleedingPB-EMBNCT07366814
Pipelle Versus Karman Endometrial Biopsy Under Standardized Paracervical Block
A study testing Pipelle Endometrial Biopsy and Karman Cannula Endometrial Biopsy in people with Abnormal Uterine Bleeding and Postmenopausal Bleeding, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Endometrial biopsy is a commonly used outpatient procedure to evaluate abnormal uterine bleeding and postmenopausal bleeding. Different sampling methods are available, but their diagnostic adequacy and patient experience may vary. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Postmenopausal Bleeding
- What is being tested?
- Pipelle Endometrial Biopsy and Karman Cannula Endometrial Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2026to 9 Feb 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years or older
- Abnormal uterine bleeding or postmenopausal bleeding requiring endometrial sampling
- Ability to provide written informed consent
- Eligible for office-based endometrial biopsy
Who cannot join
- Pregnancy
- Active pelvic infection
- Known cervical or endometrial cancer
- Severe cervical stenosis preventing endometrial sampling
- Known bleeding disorders or use of anticoagulant therapy that contraindicates biopsy
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Pipelle and Karman Endometrial Biopsy Methods Under Standardized Paracervical Block: A Prospective Randomized Study
Endometrial biopsy is a commonly used outpatient procedure to evaluate abnormal uterine bleeding and postmenopausal bleeding. Different sampling methods are available, but their diagnostic adequacy and patient experience may vary.
This prospective randomized study compares two commonly used endometrial biopsy methods, Pipelle and Karman cannula, under standardized paracervical block anesthesia. All participants receive the same local anesthetic technique to minimize pain-related differences between methods.
Read more
The primary objective is to compare the rate of clinically adequate endometrial samples obtained with each method. Secondary outcomes include patient-reported pain, patient satisfaction, procedure duration, need for additional diagnostic procedures, and hospital-related costs.
Study findings are expected to support clinical decision-making regarding the most effective and practical endometrial biopsy method when adequate pain control is provided.
Read the detailed description
Endometrial biopsy is an essential diagnostic procedure in the evaluation of abnormal uterine bleeding and postmenopausal bleeding. Office-based endometrial sampling techniques are widely used because these techniques are minimally invasive and cost-effective; however, diagnostic adequacy, patient tolerance, and resource utilization may differ between methods.
Pain during the procedure is a major factor affecting patient experience and may confound comparisons between sampling techniques. To address this limitation, participants receive a standardized paracervical block using the same anesthetic agent, dose, and technique, allowing the comparison to focus on the intrinsic performance of the biopsy methods rather than differences in analgesia.
This is a prospective, randomized, parallel-group study. Eligible participants undergoing endometrial biopsy are randomly assigned in a 1:1 ratio to either Pipelle endometrial biopsy or Karman cannula endometrial sampling. Randomization is stratified by menopausal status. Procedures are performed in an outpatient setting according to routine clinical practice.
Histopathological evaluation of endometrial samples is performed by pathologists blinded to the sampling method. Sample adequacy is assessed based on predefined criteria, with a focus on whether the specimen provides sufficient information for clinical decision-making.
In addition to diagnostic adequacy, patient-reported outcomes, including pain and satisfaction with the procedure, are assessed. Procedure duration, need for additional diagnostic interventions due to inadequate sampling, and hospital-related costs associated with each method are also evaluated.
Standardized analgesia and inclusion of clinical, patient-centered, and economic outcomes are intended to provide practical evidence to guide the selection of endometrial biopsy methods in routine gynecologic practice.
- Conditions
- Abnormal Uterine Bleeding, Postmenopausal Bleeding
- Being tested
- Pipelle Endometrial Biopsy, Karman Cannula Endometrial Biopsy
- Keywords
- Endometrial Biopsy, Pipelle, Karman Cannula, Paracervical Block, Abnormal Uterine Bleeding, Postmenopausal Bleeding, Diagnostic Adequacy, Patient Satisfaction
- Medical subject headings
- Metrorrhagia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipelle Endometrial BiopsyDevice
Also called Pipelle de Cornier
Endometrial sampling performed using a Pipelle device in an outpatient setting. The procedure is conducted under standardized paracervical block anesthesia using the same anesthetic agent, dose, and technique for all participants.
Karman Cannula Endometrial BiopsyDevice
Also called Karman Cannula, Manual Vacuum Aspiration Cannula
Endometrial sampling performed using a Karman cannula in an outpatient setting. The procedure is conducted under standardized paracervical block anesthesia using the same anesthetic agent, dose, and technique for all participants.
| Study group | Role | What they receive |
|---|---|---|
| Pipelle Endometrial Biopsy | Experimental | Participants assigned to this arm undergo office-based endometrial biopsy using a Pipelle device. All procedures are performed under standardized paracervical block anesthesia with the same anesthetic agent, dose, and technique as the other study arm. Receives: Device: Pipelle Endometrial Biopsy |
| Karman Endometrial Biopsy | Experimental | Participants assigned to this arm undergo office-based endometrial sampling using a Karman cannula. All procedures are performed under standardized paracervical block anesthesia with the same anesthetic agent, dose, and technique as the other study arm. Receives: Device: Karman Cannula Endometrial Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Adequate Endometrial Sample Rate
Proportion of endometrial biopsy samples considered clinically adequate for diagnosis based on blinded histopathological assessment.
Measured: At the index procedure (same day)
Secondary outcomes (5)
Procedure-Related Pain Score
Eligible participants undergo outpatient endometrial sampling under a standardized analgesia protocol: 3 mL of 2% prilocaine is injected for a paracervical block at the 1 and 11 o'clock positions before tenaculum application, followed by a 2-minute waiting period; a tenaculum is then applied and endometrial sampling is performed using either a Pipelle device or a 5-mm Karman cannula according to random assignment. Sampling is recorded as the number of predefined sampling cycles (maximum 3), and cervical stenosis, need for dilation, procedure duration, additional analgesia (e.g., NSAIDs), and complications are documented. Specimens are placed immediately in formalin in identical containers labeled with study ID only, sent daily in mixed order, and evaluated by pathologists blinded to sampling method for adequacy and diagnosis (including reason for inadequacy). Pain is assessed using the Visual Analog Scale for Pain (0-10; higher scores indicate worse pain) during the procedure and at 3
Measured: Periprocedural
Patient Satisfaction With the Procedure
Patient-reported satisfaction with the endometrial biopsy procedure assessed using a Likert-type questionnaire, including willingness to undergo the same procedure again if needed.
Measured: Same day after the procedure
Procedure Duration
Time required to complete the endometrial biopsy procedure, measured from speculum insertion to completion of tissue sampling.
Measured: During the procedure
Need for Additional Diagnostic Procedures
Proportion of participants requiring additional diagnostic procedures due to an inadequate endometrial biopsy sample.
Measured: Within 2 weeks after the procedure
Hospital-Related Cost per Participant
Total hospital-related cost per participant, including procedural costs and costs related to additional diagnostic interventions when required.
Measured: Within 2 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start3 Jan 2026
- Primary completion31 Jan 2026
- Study completion9 Feb 2026
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 Abnormal Uterine 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
- Model description
- Eligible participants are randomly assigned in a 1:1 ratio to undergo endometrial biopsy using either the Pipelle device or the Karman cannula, with both groups treated concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
- Investigators
- Fatma Ketenci Gencer, Assoc. Prof., Study director, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366814
- Sponsor's protocol ID
- EK-193-2025-EMB
- Acronym
- PB-EMB
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to local ethical regulations and the need to protect participant privacy. The dataset contains sensitive clinical information, and no consent for public data sharing was obtained from participants.
Publications
Coskun ES, Yeniocak AS, Bacak HB, Salman S. Optimizing analgesia for endometrial biopsy: A prospective, randomized comparative study. J Obstet Gynaecol Res. 2025 Jan;51(1):e16148. doi: 10.1111/jog.16148. Epub 2024 Nov 17.
PubMed 39551483
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pipelle and Karman Endometrial Biopsy Methods Under Standardized Paracervical Block: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07366814
- Acronym / sponsor ID
- PB-EMB / EK-193-2025-EMB
- Conditions
- Abnormal Uterine Bleeding, Postmenopausal Bleeding
- Keywords
- Endometrial Biopsy, Pipelle, Karman Cannula, Paracervical Block, Abnormal Uterine Bleeding, Postmenopausal Bleeding, Diagnostic Adequacy, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 26 Jan 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.
Endometrial biopsy is a commonly used outpatient procedure to evaluate abnormal uterine bleeding and postmenopausal bleeding. Different sampling methods are available, but their diagnostic adequacy and patient experience may vary.
This prospective randomized study compares two commonly used endometrial biopsy methods, Pipelle and Karman cannula, under standardized paracervical block anesthesia. All participants receive the same local anesthetic technique to minimize pain-related differences between methods.
The primary objective is to compare the rate of clinically adequate endometrial samples obtained with each method. Secondary outcomes include patient-reported pain, patient satisfaction, procedure duration, need for additional diagnostic procedures, and hospital-related costs.
Study findings are expected to support clinical decision-making regarding the most effective and practical endometrial biopsy method when adequate pain control is provided.
Detailed description
Endometrial biopsy is an essential diagnostic procedure in the evaluation of abnormal uterine bleeding and postmenopausal bleeding. Office-based endometrial sampling techniques are widely used because these techniques are minimally invasive and cost-effective; however, diagnostic adequacy, patient tolerance, and resource utilization may differ between methods.
Pain during the procedure is a major factor affecting patient experience and may confound comparisons between sampling techniques. To address this limitation, participants receive a standardized paracervical block using the same anesthetic agent, dose, and technique, allowing the comparison to focus on the intrinsic performance of the biopsy methods rather than differences in analgesia.
This is a prospective, randomized, parallel-group study. Eligible participants undergoing endometrial biopsy are randomly assigned in a 1:1 ratio to either Pipelle endometrial biopsy or Karman cannula endometrial sampling. Randomization is stratified by menopausal status. Procedures are performed in an outpatient setting according to routine clinical practice.
Histopathological evaluation of endometrial samples is performed by pathologists blinded to the sampling method. Sample adequacy is assessed based on predefined criteria, with a focus on whether the specimen provides sufficient information for clinical decision-making.
In addition to diagnostic adequacy, patient-reported outcomes, including pain and satisfaction with the procedure, are assessed. Procedure duration, need for additional diagnostic interventions due to inadequate sampling, and hospital-related costs associated with each method are also evaluated.
Standardized analgesia and inclusion of clinical, patient-centered, and economic outcomes are intended to provide practical evidence to guide the selection of endometrial biopsy methods in routine gynecologic practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants are randomly assigned in a 1:1 ratio to undergo endometrial biopsy using either the Pipelle device or the Karman cannula, with both groups treated concurrently.
| Arm | Type | Receives |
|---|---|---|
| Pipelle Endometrial Biopsy | Experimental | Device: Pipelle Endometrial BiopsyParticipants assigned to this arm undergo office-based endometrial biopsy using a Pipelle device. All procedures are performed under standardized paracervical block anesthesia with the same anesthetic agent, dose, and technique as the other study arm. |
| Karman Endometrial Biopsy | Experimental | Device: Karman Cannula Endometrial BiopsyParticipants assigned to this arm undergo office-based endometrial sampling using a Karman cannula. All procedures are performed under standardized paracervical block anesthesia with the same anesthetic agent, dose, and technique as the other study arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants aged 18 years or older
- Abnormal uterine bleeding or postmenopausal bleeding requiring endometrial sampling
- Ability to provide written informed consent
- Eligible for office-based endometrial biopsy
Key exclusion criteria (6 listed)
- Pregnancy
- Active pelvic infection
- Known cervical or endometrial cancer
- Severe cervical stenosis preventing endometrial sampling
- Known bleeding disorders or use of anticoagulant therapy that contraindicates biopsy
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 Endometrial BiopsyAlso: Pipelle de CornierEndometrial sampling performed using a Pipelle device in an outpatient setting. The procedure is conducted under standardized paracervical block anesthesia using the same anesthetic agent, dose, and technique for all participants. | Device | Pipelle Endometrial Biopsy |
| Karman Cannula Endometrial BiopsyAlso: Karman Cannula, Manual Vacuum Aspiration CannulaEndometrial sampling performed using a Karman cannula in an outpatient setting. The procedure is conducted under standardized paracervical block anesthesia using the same anesthetic agent, dose, and technique for all participants. | Device | Karman Endometrial Biopsy |
Primary outcome
Clinically Adequate Endometrial Sample Rate
Time frame: At the index procedure (same day)
Proportion of endometrial biopsy samples considered clinically adequate for diagnosis based on blinded histopathological assessment.
5 secondary outcomes
Procedure-Related Pain Score
Time frame: Periprocedural
Patient Satisfaction With the Procedure
Time frame: Same day after the procedure
Procedure Duration
Time frame: During the procedure
Need for Additional Diagnostic Procedures
Time frame: Within 2 weeks after the procedure
Hospital-Related Cost per Participant
Time frame: Within 2 weeks after the procedure
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 10 Feb 2026.
- Results publication: PubMed 39551483Coskun ES, Yeniocak AS, Bacak HB, Salman S. Optimizing analgesia for endometrial biopsy: A prospective, randomized comparative study. J Obstet Gynaecol Res. 2025 Jan;51(1):e16148. doi: 10.1111/jog.16148. Epub 2024 Nov 17.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to local ethical regulations and the need to protect participant privacy. The dataset contains sensitive clinical information, and no consent for public data sharing was obtained from participants.
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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.
Fatma Ketenci Gencer, Assoc. Prof. study director
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
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 Endometrial Biopsy and Karman Cannula Endometrial Biopsy in people with Abnormal Uterine Bleeding and Postmenopausal Bleeding, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 10 Feb 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 Turkey (Türkiye). 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?
Clinically Adequate Endometrial Sample Rate (time frame: At the index procedure (same day)). 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 NCT07366814, 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 10 Feb 2026.