Clinical trial · Interventional
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
The Efficacy and Safety of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions After Laparoscopic Gynecological Surgery: a Randomized Controlled Trial
NCT02166554CI-TRIAL-00014866BAPcompletedPhase 1 / Phase 2ClinicalTrials.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 was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adhesions | — | UNRESOLVED | — |
| Endometriotic Cysts | — | UNRESOLVED | — |
| Myomas | Myoma | ALIAS | 0.90 |
| Ovary Cysts | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cross-linked Hyaluronan Hydrogel | Device | — | UNRESOLVED |
| Saline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control Arm
- description
- Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery
- interventionNames
- Other: Saline
- type
- EXPERIMENTAL
- label
- Cross-linked Hyaluronan Hydrogel Arm
- description
- HyaRegen
- interventionNames
- Device: Cross-linked Hyaluronan Hydrogel
Primary outcomes (1)
- measure
- The adhesion incidence under moderate/severe category
- timeFrame
- 9 weeks following primary laparoscopic gynecological surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Female. * Aged 18-45 years. * Been scheduled for removal of myomas, ovary cysts, endometriotic cysts or adhesions. * Been willing to comply with all aspects of the treatment and evaluation schedule. * Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 9 weeks following the primary surgery. * Provided voluntary written informed consent. Exclusion Criteria: * Acute or severe infection. * Autoimmune diseases such as diabetes etc. * Abnormal liver/renal and cardiovascular function * Abnormal blood coagulation * Medical histories of peripheral vascular disease, alcohol or drug abuse, and mental illness. * Known or suspected intolerance or hypersensitivity to hyaluronan or its derivatives. * Concurrent use of systemic antiinflammatory drugs. * Clinical evidence of cancer. * Use of anticoagulant, fibrin glue, other thrombogenic agents, or any other anti-adhesion agent during the procedure. * Concurrent peritoneal grafting or tubal implantation.
References
Publications (1)
- DERIVEDLiu C, Lu Q, Zhang Z, Xue M, Zhang Y, Zhang Y, Wang H, Li H, Zhou Y, Zhang Z, Li W; HyaRegen Adhesion Study Group. A Randomized Controlled Trial on the Efficacy and Safety of a New Crosslinked Hyaluronan Gel in Reducing Adhesions after Gynecologic Laparoscopic Surgeries. J Minim Invasive Gynecol. 2015 Jul-Aug;22(5):853-63. doi: 10.1016/j.jmig.2015.04.011. Epub 2015 Apr 20. PMID 25906706