Asherman SyndromeNCT01637974
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery
A study testing INTERCOAT administration in people with Asherman Syndrome and Endometrial Polyp, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Asherman Syndrome, Endometrial Polyp, Uterine Myoma
- What is being tested?
- INTERCOAT administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Mar 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- Must be able to understand, read and sign consent form
Who cannot join
- Signs of infection upon admission
- Ongoing pregnancy
- Carcinoma of the uterus or cervix
- Recurrent PID
- Women admitted for endometrial ablation
- Women that gave birth 6 weeks ago
- Women participating in another study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa, Haifa District
Moran Paz, MD, 972-4-8250637, MORANPA@CLALIT.ORG.IL
Yuval Kaufman, MD, 972-4-8250345, mdykaufman@clalit.org.il
About this study
Official title: Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study
The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.
- Conditions
- Asherman Syndrome, Endometrial Polyp, Uterine Myoma
- Being tested
- INTERCOAT administration
- Medical subject headings
- Gynatresia, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERCOAT administrationDrug
Also called INTERCOAT
Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| with INTERCOAT | Experimental | injection of intercoat into the euterine cavity at the end of hysteroscopy Receives: Drug: INTERCOAT administration |
| without INTERCOAT | No intervention | without INTERCOAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy
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 posted11 Jul 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asherman SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moran Paz, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637974
- Sponsor's protocol ID
- CMC-11-0050-CTIL
- Status last verified
- Jul 2015
- First submitted
- 9 Jul 2012
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study
- ClinicalTrials.gov ID
- NCT01637974
- Acronym / sponsor ID
- CMC-11-0050-CTIL
- Conditions
- Asherman Syndrome, Endometrial Polyp, Uterine Myoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 11 Jul 2012 (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 study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with INTERCOAT | Experimental | Drug: INTERCOAT administrationinjection of intercoat into the euterine cavity at the end of hysteroscopy |
| without INTERCOAT | No intervention | –without INTERCOAT |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 50 years
- Must be able to understand, read and sign consent form
Key exclusion criteria (7 listed)
- Signs of infection upon admission
- Ongoing pregnancy
- Carcinoma of the uterus or cervix
- Recurrent PID
- Women admitted for endometrial ablation
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 |
|---|---|---|
| INTERCOAT administrationAlso: INTERCOATApplying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery | Drug | with INTERCOAT |
Primary outcome
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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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 INTERCOAT administration in people with Asherman Syndrome and Endometrial Polyp, run by Carmel Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 31 Jul 2015. 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 Israel. 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 Moran PAZ, M.D. (972-4-8250637, MORANPA@CLALIT.GOV.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of intra-uterine adhesions in a follow up diagnostic 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 31 Jul 2015.