MyomasPhase 1/2BAPNCT02166554
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
A Phase 1/2 study testing Saline and Cross-linked Hyaluronan Hydrogel in people with Myomas and Ovary Cysts, run by BioRegen Biomedical (Changzhou) Co., Ltd at 7 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myomas, Ovary Cysts, Endometriotic Cysts
- What is being tested?
- Saline and Cross-linked Hyaluronan Hydrogel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 7 sitesChina
- Study dates
- Jun 2011to Apr 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Hospital
Beijing, Beijing Municipality, 100730
The Third Xiangya Hospital
Changsha, Hunan, 410013
Qilu Hospital
Jinan, Shandong, 250012
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
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
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
Read the 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.
- Conditions
- Myomas, Ovary Cysts, Endometriotic Cysts, Adhesions
- Being tested
- Saline, Cross-linked Hyaluronan Hydrogel
- Keywords
- Adhesions, Hyaluronan, Gynaecological surgery, Clinical outcomes
- Medical subject headings
- Myoma, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
On the day of initial surgery
Cross-linked Hyaluronan HydrogelDevice
Also called HyaRegen, Self Cross-linked Hyaluronan Gel
On the day of the initial surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery Receives: Other: Saline |
| Cross-linked Hyaluronan Hydrogel Arm | Experimental | HyaRegen Receives: Device: Cross-linked Hyaluronan Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adhesion incidence under moderate/severe category
The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.
Measured: 9 weeks following primary laparoscopic gynecological surgery
Secondary outcomes (8)
modified American Fertility Society (mAFS) score
modified American Fertility Society (mAFS) score of ovaries/tubes
Measured: 9 weeks following primary laparoscopic gynecological surgery
Adhesion extent
Adhesion extent of ovaries/tubes
Measured: 9 weeks following primary laparoscopic gynecological surgery
Adhesion severity
Adhesion severity of ovaries/tubes
Measured: 9 weeks following primary laparoscopic gynecological surgery
The adhesion incidence under moderate/severe category
The patient percentage with modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity) more than 4 points.
Measured: 9 weeks following primary laparoscopic gynecological surgery
modified American Fertility Society (mAFS) score
modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity)
Measured: 9 weeks following primary laparoscopic gynecological surgery
Adhesion extent
Adhesion extent (throughout abdominopelvic cavity)
Measured: 9 weeks following primary laparoscopic gynecological surgery
Adhesion severity
Adhesion severity (throughout abdominopelvic cavity)
Measured: 9 weeks following primary laparoscopic gynecological surgery
Adverse events
Safety evaluation was based on clinical laboratory tests, the type and severity of adverse events recorded throughout the study, etc.
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJun 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioRegen Biomedical (Changzhou) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhenyu Zhang, MD, PhD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166554
- Sponsor's protocol ID
- FNL-2011-05
- Acronym
- BAP
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25906706
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02166554
- Acronym / sponsor ID
- BAP / FNL-2011-05
- Conditions
- Myomas, Ovary Cysts, Endometriotic Cysts, Adhesions
- Keywords
- Adhesions, Hyaluronan, Gynaecological surgery, Clinical outcomes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- BioRegen Biomedical (Changzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Other: SalineStandard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery |
| Cross-linked Hyaluronan Hydrogel Arm | Experimental | Device: Cross-linked Hyaluronan HydrogelHyaRegen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineOn the day of initial surgery | Other | Control Arm |
| Cross-linked Hyaluronan HydrogelAlso: HyaRegen, Self Cross-linked Hyaluronan GelOn the day of the initial surgery | Device | Cross-linked Hyaluronan Hydrogel Arm |
Primary outcome
The adhesion incidence under moderate/severe category
Time frame: 9 weeks following primary laparoscopic gynecological surgery
The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.
8 secondary outcomes
modified American Fertility Society (mAFS) score
Time frame: 9 weeks following primary laparoscopic gynecological surgery
Adhesion extent
Time frame: 9 weeks following primary laparoscopic gynecological surgery
Adhesion severity
Time frame: 9 weeks following primary laparoscopic gynecological surgery
The adhesion incidence under moderate/severe category
Time frame: 9 weeks following primary laparoscopic gynecological surgery
modified American Fertility Society (mAFS) score
Time frame: 9 weeks following primary laparoscopic gynecological surgery
Adhesion extent
Time frame: 9 weeks following primary laparoscopic gynecological surgery
Adhesion severity
Time frame: 9 weeks following primary laparoscopic gynecological surgery
Adverse events
Time frame: Up to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Derived from this study: PubMed 25906706Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenyu Zhang, MD, PhD principal investigator
Beijing Chao Yang Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Saline and Cross-linked Hyaluronan Hydrogel in people with Myomas and Ovary Cysts, run by BioRegen Biomedical (Changzhou) Co., Ltd at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adhesion incidence under moderate/severe category (time frame: 9 weeks following primary laparoscopic gynecological surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.