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The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions

NCT02166554 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2014-06-18

No results posted yet for this study

Summary

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

  • Myomas
  • Ovary Cysts
  • Endometriotic Cysts
  • Adhesions

Interventions

OTHER

Saline

On the day of initial surgery

DEVICE

Cross-linked Hyaluronan Hydrogel

On the day of the initial surgery

Sponsors & Collaborators

  • BioRegen Biomedical (CHangzhou) Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhenyu Zhang, MD, PhD · Beijing Chao Yang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02166554 on ClinicalTrials.gov