Postmenopausal WomenNCT01376934
Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques
A study testing procedure hysteroscopy in people with Postmenopausal Women and Hysteroscopy, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women, Hysteroscopy
- What is being tested?
- procedure hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Mar 2011
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women post-menopausal with abnormal uterine bleeding, ultrasound with thick endometrial distorted
Who cannot join
- Women with uterine malformations
- Women with mental retardation
- Women underwent pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Departamento de Tocoginecologia FCM UNICAMP
Campinas, São Paulo, 13083881
Valter Fausto Santos, graduade medicine, 5516 33717814 ext. 203, valter.fausto@yahoo.com.br
Ilza Maria Monteiro, Doctor degree, 5516 97916241, ilza@unicamp.br
About this study
Official title: Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution
Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . There are two techniques to make the procedure , one with gas and the other with saline solution. Objective: to compare two techniques concerning pain , procedure duration and image quality
Read the detailed description
The objective of this study is to compare two techniques in office hysteroscopy.In this clinical trial postmenopausal women will undergo a diagnostic hysteroscopy using carbon dioxide or saline solution to uterine cavity distension.
There will be two groups of 70 women each. The objective is to determine which technique provides better image,time of procedure and less discomfort.
- Conditions
- Postmenopausal Women, Hysteroscopy
- Being tested
- procedure hysteroscopy
- Keywords
- hysteroscopy, saline solution, carbon dioxide, compare two techniques in office hysteroscopy co2 and saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedure hysteroscopyProcedure or surgery
office hysteroscopy with gas or saline solution
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the comfort in office hysteroscopy
140 women will undergo office hysteroscopy to evaluate pain, time of the procedure and image quality using two techniques one with gas and the other with saline solution.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies 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
- Health services research
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Valter Fausto Santos, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376934
- Sponsor's protocol ID
- 01/2011/PC
- Status last verified
- Jun 2011
- First submitted
- 16 Jun 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution
- ClinicalTrials.gov ID
- NCT01376934
- Acronym / sponsor ID
- 01/2011/PC
- Conditions
- Postmenopausal Women, Hysteroscopy
- Keywords
- hysteroscopy, saline solution, carbon dioxide, compare two techniques in office hysteroscopy co2 and saline solution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (actual)
- First posted
- 20 Jun 2011 (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.
Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . There are two techniques to make the procedure , one with gas and the other with saline solution. Objective: to compare two techniques concerning pain , procedure duration and image quality
Detailed description
The objective of this study is to compare two techniques in office hysteroscopy.In this clinical trial postmenopausal women will undergo a diagnostic hysteroscopy using carbon dioxide or saline solution to uterine cavity distension.
There will be two groups of 70 women each. The objective is to determine which technique provides better image,time of procedure and less discomfort.
Study design
- Primary purpose
- Health services research
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women post-menopausal with abnormal uterine bleeding, ultrasound with thick endometrial distorted
Key exclusion criteria (3 listed)
- Women with uterine malformations
- Women with mental retardation
- Women underwent pelvic radiotherapy
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 |
|---|---|---|
| procedure hysteroscopyoffice hysteroscopy with gas or saline solution | Procedure or surgery | – |
Primary outcome
Evaluation of the comfort in office hysteroscopy
Time frame: one year
140 women will undergo office hysteroscopy to evaluate pain, time of the procedure and image quality using two techniques one with gas and the other with saline solution.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
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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.
Departamento de Tocoginecologia FCM UNICAMP
Campinas, Brazil
Valter Fausto Santos principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procedure hysteroscopy in people with Postmenopausal Women and Hysteroscopy, run by University of Campinas, Brazil at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Jun 2011. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the comfort in office hysteroscopy (time frame: one year). 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 20 Jun 2011.