MenorrhagiaNCT01969396
Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology
A study testing SonoBiopsy Catheter and Endometrial biopsy catheter in people with Menorrhagia and Endometrial Neoplasms, run by Cook Group Incorporated at 1 site in Panama.
Trial summary
To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menorrhagia, Endometrial Neoplasms, Polycystic Ovary Syndrome
- What is being tested?
- SonoBiopsy Catheter and Endometrial biopsy catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 sitePanama
- Study dates
- Oct 2013to Sep 2014
- 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
- Patient with thickened endometrium
- Abnormal uterine bleeding
Who cannot join
- Pregnant
- Active pelvic infection
- Pelvic inflammatory disease
- Blood clotting disorders
- Sexually transmitted disease
- Uterine perforation
- Recent cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.
- Being tested
- SonoBiopsy Catheter, Endometrial biopsy catheter
- Keywords
- Biopsy, Endometrial biopsy, Endometrial sampling, sonohysterography
- Medical subject headings
- Menorrhagia, Endometrial Neoplasms, Polycystic Ovary Syndrome, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoBiopsy CatheterDevice
Also called Endometrial biopsy with sonohysterography
Catheter utilized in dual role: sonohysterography and endometrial biopsy
Endometrial biopsy catheterDevice
Also called Endometrial biopsy
Endometrial sample obtained without the assistance of sonohysterography
| Study group | Role | What they receive |
|---|---|---|
| SonoBiopsy Catheter | Experimental | Not described Receives: Device: SonoBiopsy Catheter |
| Endometrial biopsy catheter | Active comparator | Not described Receives: Device: Endometrial biopsy catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of adequate endometrial biopsies utilizing sonohysterography
Measured: 7 days
percentage of adequate endometrial biopsies collected without sonohysterography
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Enrollment considerations and current status of the clinical study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Mastellari, MD, Principal investigator, Hospital Punta Pacifica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969396
- Sponsor's protocol ID
- 12-012
- Status last verified
- Dec 2014
- First submitted
- 17 Oct 2013
- Last updated
- 23 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology
- ClinicalTrials.gov ID
- NCT01969396
- Acronym / sponsor ID
- 12-012
- Keywords
- Biopsy, Endometrial biopsy, Endometrial sampling, sonohysterography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment considerations and current status of the clinical study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Oct 2013 (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.
To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SonoBiopsy Catheter | Experimental | Device: SonoBiopsy Catheter |
| Endometrial biopsy catheter | Active comparator | Device: Endometrial biopsy catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with thickened endometrium
- Abnormal uterine bleeding
Key exclusion criteria (7 listed)
- Pregnant
- Active pelvic infection
- Pelvic inflammatory disease
- Blood clotting disorders
- Sexually transmitted disease
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 |
|---|---|---|
| SonoBiopsy CatheterAlso: Endometrial biopsy with sonohysterographyCatheter utilized in dual role: sonohysterography and endometrial biopsy | Device | SonoBiopsy Catheter |
| Endometrial biopsy catheterAlso: Endometrial biopsyEndometrial sample obtained without the assistance of sonohysterography | Device | Endometrial biopsy catheter |
Primary outcome
percentage of adequate endometrial biopsies utilizing sonohysterography
Time frame: 7 days
percentage of adequate endometrial biopsies collected without sonohysterography
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Enrollment considerations and current status of the clinical study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
Ricardo Mastellari, MD principal investigator
Hospital Punta Pacifica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonoBiopsy Catheter and Endometrial biopsy catheter in people with Menorrhagia and Endometrial Neoplasms, run by Cook Group Incorporated at 1 site in Panama.
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 7 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: stopped early, as of the sponsor's last update on 23 Dec 2014. 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 Panama. 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 was stopped early (reason given: Enrollment considerations and current status of the clinical study). Results are not available in the source record.
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?
percentage of adequate endometrial biopsies utilizing sonohysterography (time frame: 7 days). 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?
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 Dec 2014.