NCT04702399|Unknown
Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy
PREVENDO
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PREVENDO
Sponsor study identifier
interventional
76
0 countries
N/A
Study Start
February 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL ENDO)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2021
Actual (reported)January 8, 2021
Actual (reported)February 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The proportion of patients with endometrial synechiae
The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery.
6 weeks after surgery (+/-2weeks)
Proportion of patients with moderate or severe endometrial synechiae
6 weeks after surgery (+/-2 weeks)
Proportion of patients with increased of menstrual bleeding or menstrual bleeding time
6 weeks after surgery (+/- 2 weeks)
The quality of life
6 weeks after surgery (+/- 2 weeks)
Dysmenorrhea
6 weeks after surgery (+/- 2 weeks)
Spontaneous pelvic pain
6 weeks after surgery (+/- 2 weeks)
Intracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO)
No Intervention
Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Geoffroy Doctor CANLORBE
Assistance Publique - Hôpitaux de Paris
First Submitted
January 7, 2021
First Posted
January 8, 2021
Study Start
February 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 1, 2022
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 8, 2021
Record last verified: 2020-11
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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