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

Primary Purpose

Myomas, Ovary Cysts, Endometriotic Cysts

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Saline
Cross-linked Hyaluronan Hydrogel
Sponsored by
BioRegen Biomedical (CHangzhou) Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myomas focused on measuring Adhesions, Hyaluronan, Gynaecological surgery, Clinical outcomes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chao-Yang Hospital
  • China-Japan Friendship Hospital
  • Peking University First Hospital
  • Beijing Hospital
  • The Second Hospital of Hebei Medical University
  • The Third Xiangya Hospital
  • Qilu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Arm

Cross-linked Hyaluronan Hydrogel Arm

Arm Description

Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery

HyaRegen

Outcomes

Primary Outcome Measures

The adhesion incidence under moderate/severe category
The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.

Secondary Outcome Measures

modified American Fertility Society (mAFS) score
modified American Fertility Society (mAFS) score of ovaries/tubes
Adhesion extent
Adhesion extent of ovaries/tubes
Adhesion severity
Adhesion severity of ovaries/tubes
The adhesion incidence under moderate/severe category
The patient percentage with modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity) more than 4 points.
modified American Fertility Society (mAFS) score
modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity)
Adhesion extent
Adhesion extent (throughout abdominopelvic cavity)
Adhesion severity
Adhesion severity (throughout abdominopelvic cavity)
Adverse events
Safety evaluation was based on clinical laboratory tests, the type and severity of adverse events recorded throughout the study, etc.

Full Information

First Posted
June 13, 2014
Last Updated
June 16, 2014
Sponsor
BioRegen Biomedical (CHangzhou) Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02166554
Brief Title
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
Acronym
BAP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioRegen Biomedical (CHangzhou) Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed Description
Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myomas, Ovary Cysts, Endometriotic Cysts, Adhesions
Keywords
Adhesions, Hyaluronan, Gynaecological surgery, Clinical outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery
Arm Title
Cross-linked Hyaluronan Hydrogel Arm
Arm Type
Experimental
Arm Description
HyaRegen
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
On the day of initial surgery
Intervention Type
Device
Intervention Name(s)
Cross-linked Hyaluronan Hydrogel
Other Intervention Name(s)
HyaRegen, Self Cross-linked Hyaluronan Gel
Intervention Description
On the day of the initial surgery
Primary Outcome Measure Information:
Title
The adhesion incidence under moderate/severe category
Description
The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.
Time Frame
9 weeks following primary laparoscopic gynecological surgery
Secondary Outcome Measure Information:
Title
modified American Fertility Society (mAFS) score
Description
modified American Fertility Society (mAFS) score of ovaries/tubes
Time Frame
9 weeks following primary laparoscopic gynecological surgery
Title
Adhesion extent
Description
Adhesion extent of ovaries/tubes
Time Frame
9 weeks following primary laparoscopic gynecological surgery
Title
Adhesion severity
Description
Adhesion severity of ovaries/tubes
Time Frame
9 weeks following primary laparoscopic gynecological surgery
Title
The adhesion incidence under moderate/severe category
Description
The patient percentage with modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity) more than 4 points.
Time Frame
9 weeks following primary laparoscopic gynecological surgery
Title
modified American Fertility Society (mAFS) score
Description
modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity)
Time Frame
9 weeks following primary laparoscopic gynecological surgery
Title
Adhesion extent
Description
Adhesion extent (throughout abdominopelvic cavity)
Time Frame
9 weeks following primary laparoscopic gynecological surgery
Title
Adhesion severity
Description
Adhesion severity (throughout abdominopelvic cavity)
Time Frame
9 weeks following primary laparoscopic gynecological surgery
Title
Adverse events
Description
Safety evaluation was based on clinical laboratory tests, the type and severity of adverse events recorded throughout the study, etc.
Time Frame
Up to 9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang, MD, PhD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
The Third Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Qilu Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25906706
Citation
Liu 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.
Results Reference
derived

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

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