Gynecologic DiseasePhase 3antiadhesionNCT03007654
Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)
A Phase 3 study testing Mediclore and Adept in people with Gynecologic Disease, run by Yong Sang Song at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Mediclore and Adept
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Aug 2017
- Phase
- Phase 3
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Gynecological disease (benign disease)
- Patients who Written informed consent
- Patients without clinically significant lab
Who cannot join
- having enrolled another clinical trials within 1 month
- Immunosuppression or autoimmune disease
- Anticoagulant, general steroids within a week from surgery
- Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
- Patients with previous history of surgery at the same operate site
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoutl National University Hospital
Seoul
Yong sang Song, MD, +82-10-9580-1023
Maria Lee, MD, +82-10-2991-9692, marialee@snu.ac.kr
About this study
Official title: Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
- Conditions
- Gynecologic Disease
- Being tested
- Mediclore, Adept
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedicloreDevice
Also called Poloxamer, Gelatin and Chitosan.
apply medical device fully around intrauterine surgery area
AdeptDevice
apply medical device fully around intrauterine surgery area
| Study group | Role | What they receive |
|---|---|---|
| Mediclore | Experimental | adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area Receives: Device: Mediclore |
| No treatment | No intervention | standard treatment for surgery |
| Adept | Active comparator | adhesion barrier, Adept, to apply medical device fully around surgery area Receives: Device: Adept |
What is being measured
The primary outcome is the main question the study is designed to answer.
adhesion rate
4 weeks after surgery, finding adhesion using visceral slide test
Measured: 4 weeks after surgery
Secondary outcomes (2)
Incidence of adhesion symptoms
4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire
Measured: 4 weeks after surgery
adverse event
identifying adverse events after surgery
Measured: 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong Sang Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Sang Song, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007654
- Sponsor's protocol ID
- CG-AHS008
- Acronym
- antiadhesion
- Status last verified
- Jan 2017
- First submitted
- 30 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study
- ClinicalTrials.gov ID
- NCT03007654
- Acronym / sponsor ID
- antiadhesion / CG-AHS008
- Conditions
- Gynecologic Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Yong Sang SongUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 2 Jan 2017 (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 is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediclore | Experimental | Device: Medicloreadhesion barrier Mediclore 5cc, to apply medical device fully around surgery area |
| No treatment | No intervention | –standard treatment for surgery |
| Adept | Active comparator | Device: Adeptadhesion barrier, Adept, to apply medical device fully around surgery area |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Gynecological disease (benign disease)
- Patients who Written informed consent
- Patients without clinically significant lab
Key exclusion criteria (5 listed)
- having enrolled another clinical trials within 1 month
- Immunosuppression or autoimmune disease
- Anticoagulant, general steroids within a week from surgery
- Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
- Patients with previous history of surgery at the same operate site
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 |
|---|---|---|
| MedicloreAlso: Poloxamer, Gelatin and Chitosan.apply medical device fully around intrauterine surgery area | Device | Mediclore |
| Adeptapply medical device fully around intrauterine surgery area | Device | Adept |
Primary outcome
adhesion rate
Time frame: 4 weeks after surgery
4 weeks after surgery, finding adhesion using visceral slide test
2 secondary outcomes
Incidence of adhesion symptoms
Time frame: 4 weeks after surgery
adverse event
Time frame: 4 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mediclore and Adept in people with Gynecologic Disease, run by Yong Sang Song at 1 site in South Korea.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongsang Song, MD (+82-10-9580-1023, yssong@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adhesion rate (time frame: 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2017.