Abnormal Uterine BleedingNCT00755651
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
A study testing Endometrial biopsy in people with Abnormal Uterine Bleeding, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
Trial summary
The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- Endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2003to May 2007
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication to carry out diagnostic hysteroscopy
- Agrees and is suitable for outpatient/office hysteroscopy
Who cannot join
- Failed outpatient/office hysteroscopy
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.
Read the detailed description
We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- Endometrial biopsy
- Keywords
- Menorrhagia, Uterine fibroids, Endometrial polyps, Endometrial cancer
- Medical subject headings
- Metrorrhagia, Menorrhagia, Leiomyoma, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsyProcedure or surgery
Also called Pipelle, H Pipelle
Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| H Pipelle | Experimental | Endometrial sample obtained using the H Pipelle Receives: Procedure: Endometrial biopsy |
| Pipelle | Active comparator | Endometrial sample obtained with standard Pipelle Receives: Procedure: Endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort
Measured: End of procedure
Secondary outcomes (1)
Procedure time, biopsy adequacy
Measured: End of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startJan 2003
- Primary completionMay 2007
- Study completionMay 2007
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
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hampstead NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Adam Magos, BSc MD FRCOG, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755651
- Sponsor's protocol ID
- REC 6056
- Status last verified
- Sep 2008
- First submitted
- 18 Sep 2008
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Sharma M, Taylor A, di Spiezio Sardo A, Buck L, Mastrogamvrakis G, Kosmas I, Tsirkas P, Magos A. Outpatient hysteroscopy: traditional versus the 'no-touch' technique. BJOG. 2005 Jul;112(7):963-7. doi: 10.1111/j.1471-0528.2005.00425.x.
PubMed 15958000
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
- ClinicalTrials.gov ID
- NCT00755651
- Acronym / sponsor ID
- REC 6056
- Conditions
- Abnormal Uterine Bleeding
- Keywords
- Menorrhagia, Uterine fibroids, Endometrial polyps, Endometrial cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Royal Free Hampstead NHS TrustUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 19 Sep 2008 (estimated)
- 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 investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.
Detailed description
We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H Pipelle | Experimental | Procedure: Endometrial biopsyEndometrial sample obtained using the H Pipelle |
| Pipelle | Active comparator | Procedure: Endometrial biopsyEndometrial sample obtained with standard Pipelle |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication to carry out diagnostic hysteroscopy
- Agrees and is suitable for outpatient/office hysteroscopy
Key exclusion criteria (1 listed)
- Failed outpatient/office hysteroscopy
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 biopsyAlso: Pipelle, H PipelleEndometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy | Procedure or surgery | H Pipelle, Pipelle |
Primary outcome
Discomfort
Time frame: End of procedure
1 secondary outcome
Procedure time, biopsy adequacy
Time frame: End of 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 19 Sep 2008.
- Results publication: PubMed 15958000Sharma M, Taylor A, di Spiezio Sardo A, Buck L, Mastrogamvrakis G, Kosmas I, Tsirkas P, Magos A. Outpatient hysteroscopy: traditional versus the 'no-touch' technique. BJOG. 2005 Jul;112(7):963-7. doi: 10.1111/j.1471-0528.2005.00425.x.
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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.
Adam Magos, BSc MD FRCOG principal investigator
Royal Free Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial biopsy in people with Abnormal Uterine Bleeding, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
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 1 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 19 Sep 2008. 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 Kingdom. 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?
Discomfort (time frame: End of procedure). 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 NCT00755651, 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 19 Sep 2008.