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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01412489 |
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Date of registration:
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16/05/2011 |
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Primary sponsor: |
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Public title:
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Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel
HYGEM |
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Scientific title:
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Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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220 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01412489 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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France
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Contacts
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Name:
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Jean-Louis Benifla, MD, PhD |
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Address:
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Telephone:
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+ 33 (0)1 44 73 51 18 |
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Email:
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jl.benifla@trs.aphp.fr |
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Affiliation:
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Name:
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Jean-Louis Benifla, MD, PhD |
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Address:
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Telephone:
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+ 33 (0)1 44 73 51 18 |
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Email:
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jl.benifla@trs.aphp.fr |
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Affiliation:
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Name:
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Jean-Louis Benifla, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 to 45 aged-patients
- hysteroscopic diagnosis of one submucous myoma with less than 3cm diameter requiring
operative hysteroscopy with saline type 0, 1 or 2
- negative plasmatic ßHCG test
- non opposition
- patients with social security
Exclusion Criteria:
- multiple submucous myomas type 0, 1 or 2
- presurgical embolization
- presurgical impregnation with GnRH agonist
- coagulative disorders
- malignancies
- uncontrolled diabetes
- operative hysteroscopy with glycine
- known hypersensitivity to HyalobarrierR Gel Endo
- infection of the surgical area concerned
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Myoma
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Intervention(s)
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Device: HYALOBARRIER Gel
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Primary Outcome(s)
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The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy
[Time Frame: between 4 and 8 weeks after initial hysteroscopic myomectomy]
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Secondary Outcome(s)
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Postsurgical fertility with evaluation of number of participants who became pregnant after surgery, spontaneously and/or after assisted reproductive technologies
[Time Frame: 2 years]
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the number of participants with adverse events as a measure of safety and tolerability during the time of the study
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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