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Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel (HYGEM)

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ClinicalTrials.gov Identifier: NCT01412489
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the intrauterine adhesion rate after the application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were tolerance and side effect and subsequent fertility.

Condition or disease Intervention/treatment
Myoma Device: HYALOBARRIER Gel

Detailed Description:
Hysteroscopic myomectomy is the referent surgical treatment for submucous myoma. But intrauterine adhesion rate was evaluated about 7 to 15% after this procedure. The investigators hypothetically believe that application of HYALOBARRIER Gel at the end of the procedure, could be reduce the mean intrauterine rate to 50%. Thus, the investigators performed a multicenter (n = 20) prospective study non randomized in 220 patients with submucous myoma < 3 cm of diameter, evaluated by preoperative ultrasound. The investigators prefer this study design, because the principal reason is the number of enrolled patient were more 200 patients in each group with a double blind randomized study. Now, in all patients, after hysteroscopic myomectomy which performed with a same technique in each center (bipolar coagulation and physiologic serum), a diagnostic hysteroscopy was performed at 2 month to determinate the existence of intrauterine adhesion. Secondary end points were in this study the tolerance and side effects of HYALOBARRIER Gel and the subsequent fertility at 2 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study
Actual Study Start Date : August 2011
Primary Completion Date : December 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure
Device: HYALOBARRIER Gel
For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. the number of participants with adverse events as a measure of safety and tolerability during the time of the study [ Time Frame: 2 years ]
  2. Postsurgical fertility with evaluation of number of participants who became pregnant after surgery, spontaneously and/or after assisted reproductive technologies [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 βHCG 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412489


Locations
France
Service de Gynecologie-Obstetrique, Hopital Lariboisière
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Louis Benifla, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01412489     History of Changes
Other Study ID Numbers: K 100801
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Uterine synechiae
HyalobarrierR Gel Endo
Operative hysteroscopy
submucous myoma