Hysteroscopy, Distension Medium, PainNCT02958722
Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy
A study testing diagnostic hysteroscopy, physiological solution and carbon dioxide in people with Hysteroscopy, Distension Medium, Pain, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hysteroscopy, Distension Medium, Pain
- What is being tested?
- diagnostic hysteroscopy, physiological solution and carbon dioxide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Apr 2017
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected uterine pathologies
- infertility
Who cannot join
- pregnancy
- severe hypertension, cardiovascular disease or respiratory disease
About this study
Official title: CO2 or Physiological Solution as Distension Medium: Which One is Better in Diagnostic Hysteroscopy?
The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination.
- Conditions
- Hysteroscopy, Distension Medium, Pain
- Being tested
- diagnostic hysteroscopy, physiological solution, carbon dioxide
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic hysteroscopyProcedure or surgery
Endoscopic procedure to visualize uterine cavity
physiological solutionDrug
carbon dioxideDrug
| Study group | Role | What they receive |
|---|---|---|
| carbon dioxide | Active comparator | Diagnostic hysteroscopy performed with the carbon dioxide (gas) Receives: Procedure: diagnostic hysteroscopy; Drug: carbon dioxide |
| physiological solution | Active comparator | Diagnostic hysteroscopy performed with liquid solution (physiologic solution) Receives: Procedure: diagnostic hysteroscopy; Drug: physiological solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain discomfort during the procedure assessed through visual analogue scale (VAS)
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysteroscopy, Distension Medium, PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958722
- Sponsor's protocol ID
- ISC2
- Status last verified
- Nov 2016
- First submitted
- 21 Oct 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 or Physiological Solution as Distension Medium: Which One is Better in Diagnostic Hysteroscopy?
- ClinicalTrials.gov ID
- NCT02958722
- Acronym / sponsor ID
- ISC2
- Conditions
- Hysteroscopy, Distension Medium, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Nov 2016 (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 aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carbon dioxide | Active comparator | Procedure: diagnostic hysteroscopy, Drug: carbon dioxideDiagnostic hysteroscopy performed with the carbon dioxide (gas) |
| physiological solution | Active comparator | Procedure: diagnostic hysteroscopy, Drug: physiological solutionDiagnostic hysteroscopy performed with liquid solution (physiologic solution) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suspected uterine pathologies
- infertility
Key exclusion criteria (2 listed)
- pregnancy
- severe hypertension, cardiovascular disease or respiratory 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 |
|---|---|---|
| diagnostic hysteroscopyEndoscopic procedure to visualize uterine cavity | Procedure or surgery | carbon dioxide, physiological solution |
| physiological solution | Drug | physiological solution |
| carbon dioxide | Drug | carbon dioxide |
Primary outcome
pain discomfort during the procedure assessed through visual analogue scale (VAS)
Time frame: up to six months
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 6 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Hysteroscopy, Distension Medium, Pain
Not yet recruiting
Warm Versus Room Temperature Saline as a Uterine Distension Medium for Pain Reduction in Women Undergoing Outpatient Hysteroscopy: Protocol for a Randomized Controlled Trial
Pain During Outpatient Hysteroscopy, Pain Reduction in Outpatient Hysteroscopy
Recruiting
Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy
Post-operative Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic hysteroscopy, physiological solution and carbon dioxide in people with Hysteroscopy, Distension Medium, Pain, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 2 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 6 Oct 2017. 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.
What does the primary outcome measure?
pain discomfort during the procedure assessed through visual analogue scale (VAS) (time frame: up to six months). 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 6 Oct 2017.