Endometrial DiseaseNCT02691715
Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding
A study testing Endometrial saline plus curettage and Endometrial curettage in people with Endometrial Disease, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigator will examined the diagnostic effect of the endometrial washing by saline. Because this technique more less painful and easier compared to endometrial curettage. Participants will separate into two groups. Read more about this study
- Who is it for?
- Ages 35 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Disease
- What is being tested?
- Endometrial saline plus curettage and Endometrial curettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Jun 2016
- 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 35 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Abnormal uterine bleeding
Who cannot join
- Involuntary, under 35 years old,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Istanbul, 34668
About this study
Investigator will examined the diagnostic effect of the endometrial washing by saline. Because this technique more less painful and easier compared to endometrial curettage. Participants will separate into two groups. In study groups before endometrial curettage 5 cc saline infused to the endometrial cavity then aspirate and put into thin prep to examined. After this procedure routine endometrial curettage will be done. In control group only endometrial curettage will be done. Pathologic results of thin prep and curettage will compared.
- Conditions
- Endometrial Disease
- Being tested
- Endometrial saline plus curettage, Endometrial curettage
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial saline plus curettageProcedure or surgery
Endometrial curettageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endometrial saline plus curettage | Experimental | 5 cc saline infused to the endometrial cavity and aspirated. Then routine endometrial curettage performed for same participant. Receives: Procedure: Endometrial saline plus curettage |
| Endometrial curettage | Active comparator | Only routine endometrial curettage performed Receives: Procedure: Endometrial curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical cytological results according to Bethesda 2003
for endometrial washing sample
Measured: 1 month
Endometrial hyperplasiz classification according to World Health Organization 2013
for endometrial curretage sampling
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endometrial DiseaseStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691715
- Sponsor's protocol ID
- 168
- Status last verified
- Apr 2016
- First submitted
- 28 Jan 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moschos E, Ashfaq R, McIntire DD, Liriano B, Twickler DM. Saline-infusion sonography endometrial sampling compared with endometrial biopsy in diagnosing endometrial pathology. Obstet Gynecol. 2009 Apr;113(4):881-887. doi: 10.1097/AOG.0b013e31819b3fc7.
PubMed 19305334Rotenberg O, Renz M, Reimers L, Doulaveris G, Gebb J, Goldberg GL, Dar P. Simultaneous endometrial aspiration and sonohysterography for the evaluation of endometrial pathology in women aged 50 years and older. Obstet Gynecol. 2015 Feb;125(2):414-423. doi: 10.1097/AOG.0000000000000631.
PubMed 25568988Bese T, Demirkiran F, Guralp O, Sanioglu C, Arvas M. Transtubal transport of carcinoma cells into the peritoneal cavity after saline infusion via transcervical route in patients with endometrial carcinoma. Int J Gynecol Cancer. 2009 May;19(4):682-5. doi: 10.1111/IGC.0b013e3181a48c7f.
PubMed 19509571
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT02691715
- Acronym / sponsor ID
- 168
- Conditions
- Endometrial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Feb 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.
Investigator will examined the diagnostic effect of the endometrial washing by saline. Because this technique more less painful and easier compared to endometrial curettage. Participants will separate into two groups. In study groups before endometrial curettage 5 cc saline infused to the endometrial cavity then aspirate and put into thin prep to examined. After this procedure routine endometrial curettage will be done. In control group only endometrial curettage will be done. Pathologic results of thin prep and curettage will compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial saline plus curettage | Experimental | Procedure: Endometrial saline plus curettage5 cc saline infused to the endometrial cavity and aspirated. Then routine endometrial curettage performed for same participant. |
| Endometrial curettage | Active comparator | Procedure: Endometrial curettageOnly routine endometrial curettage performed |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Abnormal uterine bleeding
Key exclusion criteria (1 listed)
- Involuntary, under 35 years old,
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 saline plus curettage | Procedure or surgery | Endometrial saline plus curettage |
| Endometrial curettage | Procedure or surgery | Endometrial curettage |
Primary outcome
Cervical cytological results according to Bethesda 2003
Time frame: 1 month
for endometrial washing sample
Endometrial hyperplasiz classification according to World Health Organization 2013
Time frame: 1 month
for endometrial curretage sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Results publication: PubMed 19305334Moschos E, Ashfaq R, McIntire DD, Liriano B, Twickler DM. Saline-infusion sonography endometrial sampling compared with endometrial biopsy in diagnosing endometrial pathology. Obstet Gynecol. 2009 Apr;113(4):881-887. doi: 10.1097/AOG.0b013e31819b3fc7.
- Results publication: PubMed 25568988Rotenberg O, Renz M, Reimers L, Doulaveris G, Gebb J, Goldberg GL, Dar P. Simultaneous endometrial aspiration and sonohysterography for the evaluation of endometrial pathology in women aged 50 years and older. Obstet Gynecol. 2015 Feb;125(2):414-423. doi: 10.1097/AOG.0000000000000631.
- Results publication: PubMed 19509571Bese T, Demirkiran F, Guralp O, Sanioglu C, Arvas M. Transtubal transport of carcinoma cells into the peritoneal cavity after saline infusion via transcervical route in patients with endometrial carcinoma. Int J Gynecol Cancer. 2009 May;19(4):682-5. doi: 10.1111/IGC.0b013e3181a48c7f.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
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 saline plus curettage and Endometrial curettage in people with Endometrial Disease, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 27 Apr 2016. 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 Turkey (Türkiye). 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?
Contact Mehmet Baki Şentürk, MD (+90 541 773 71 76, dr.baki77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical cytological results according to Bethesda 2003 (time frame: 1 month). 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?
On the ClinicalTrials.gov record for NCT02691715, which also lists 3 linked publications.
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 27 Apr 2016.