Uterine Cervical DysplasiaNCT00266084
Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix
An observational study of Uterine Cervical Dysplasia and Uterine Cervical Intraepithelial Neoplasia, run by University Hospitals Cleveland Medical Center.
Trial summary
This study tested the safety and performance of a new cell collector device and compared the results to those obtained with the current existing device that are being used routinely Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Uterine Cervical Dysplasia, Uterine Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasia
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to Nov 2001
- Phase
- Observational
- 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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women ages >14 being followed for a previous abnormal Pap All patients will have signed an Informed Consent form prior to being enrolled in this study
Who cannot join
- Patients who have had a hysterectomy
About this study
Official title: Double-Blinded Multicenter Clinical Study Assessing the Equivalence of the InPath Cervical Cell Collector to the Standard Endocervical Brush and Spatula in Patients Seeking Primary Pap Screening or Follow-up Screening
This study tested the safety and performance of a new cell collector device and compared the results to those obtained with the current existing device that are being used routinely
Read the detailed description
This study tested the feasibility, safety and efficacy of the new e2TM Collector, and compared its performance with the standard method for obtaining cervical cells for Pap test of endocervical cytobrush and Ayer's Spatula
- Conditions
- Uterine Cervical Dysplasia, Uterine Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasia, Uterine Cervical Cancer
- Keywords
- Cervix, Uterus, Dysplasia, Cancer, Collector
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startAug 1999
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical DysplasiaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 85 participants
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- George I Gorodeski, MD PhD, Principal investigator, University Hospitals of Cleveland, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266084
- Sponsor's protocol ID
- 02-00-16
- Status last verified
- Nov 2001
- First submitted
- 14 Dec 2005
- Last updated
- 11 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blinded Multicenter Clinical Study Assessing the Equivalence of the InPath Cervical Cell Collector to the Standard Endocervical Brush and Spatula in Patients Seeking Primary Pap Screening or Follow-up Screening
- ClinicalTrials.gov ID
- NCT00266084
- Acronym / sponsor ID
- 02-00-16
- Conditions
- Uterine Cervical Dysplasia, Uterine Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasia, Uterine Cervical Cancer
- Keywords
- Cervix, Uterus, Dysplasia, Cancer, Collector
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Aug 1999
- Study completion
- Nov 2001
- First posted
- 15 Dec 2005 (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.
This study tested the safety and performance of a new cell collector device and compared the results to those obtained with the current existing device that are being used routinely
Detailed description
This study tested the feasibility, safety and efficacy of the new e2TM Collector, and compared its performance with the standard method for obtaining cervical cells for Pap test of endocervical cytobrush and Ayer's Spatula
Study design
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women ages >14 being followed for a previous abnormal Pap All patients will have signed an Informed Consent form prior to being enrolled in this study
Key exclusion criteria (1 listed)
- Patients who have had a hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 11 May 2016.
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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.
George I Gorodeski, MD PhD principal investigator
University Hospitals of Cleveland, Case Western Reserve University
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Dysplasia and Uterine Cervical Intraepithelial Neoplasia, run by University Hospitals Cleveland Medical Center.
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 1 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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 11 May 2016.