Clinical trial · Interventional
Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel
Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study
NCT01412489CI-TRIAL-00026664HYGEMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myoma | Myoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HYALOBARRIER Gel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure
- interventionNames
- Device: HYALOBARRIER Gel
Primary outcomes (1)
- measure
- The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy
- timeFrame
- between 4 and 8 weeks after initial hysteroscopic myomectomy
Secondary outcomes (2)
- measure
- the number of participants with adverse events as a measure of safety and tolerability during the time of the study
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.