Genital Diseases, FemalePhase 3GUARDIX-FLNCT02097446
Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy
A Phase 3 study testing Guardix-FL and Interceed in people with Genital Diseases, Female, run by Genewel Co., Ltd at 1 site in South Korea.
Trial summary
Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma) Intervention: Device ( Test group : Guardix-FL, Control group : Interceed) Primary Outcome Measure : Anti-adhesion Rate Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4)… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Genital Diseases, Female
- What is being tested?
- Guardix-FL and Interceed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento Jan 2015
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The patients who sign the written informed consent
- Women aged between 18 and 44
- The patients who are able to participate in clinical trial during the period of study
- The patients without abnormal figures at the screening laboratory examination
- The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma)
Who cannot join
- The patients who took treatments with medical products which might be barrier to evaluate the effectiveness
- The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants
- The patients with severe drug allergy
- The patients with infectious disease on abdominal or pelvic cavity
- The patients who previously participated in another clinical trials within the past 30 days
- The patients considered inappropriate for the study
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- The pregnant
- The patients with severe renal disease
- The patients with severe systemic diseases
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Seoul Hospital
Seoul, Seoul, 133-792
Hae Jeong Kim, Bachelor's, 82-10-2987-0960, lovejunjung@hanmail.net
About this study
Official title: Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study
- Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma)
- Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)
- Primary Outcome Measure : Anti-adhesion Rate
- Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)
- Conditions
- Genital Diseases, Female
- Being tested
- Guardix-FL, Interceed
- Keywords
- cystectomy
- 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.
Guardix-FLDevice
InterceedDevice
| Study group | Role | What they receive |
|---|---|---|
| GUARDIX-FL | Experimental | Patients will be treated with 1 or 2 sheet of GUARDIX-FL after ovarian cystectomy(Operative Day). Receives: Device: Guardix-FL |
| Interceed | Active comparator | Patients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day). Receives: Device: Interceed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Adhesion Rate
Adhesion yes or no
Measured: Post-Operative Day+4weeks(Second - look)
Secondary outcomes (1)
Score
Length of Adhesion x Grade of Adhesion
Measured: Post-Operative Day+4weeks(Second-look)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Diseases, FemaleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genewel Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joong Sub Choi, Ph.D, Study director, Hanyang University Seoul HospitalSeong Hun Kim, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097446
- Sponsor's protocol ID
- Genewel1301
- Acronym
- GUARDIX-FL
- Status last verified
- Mar 2014
- First submitted
- 21 Mar 2014
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02097446
- Acronym / sponsor ID
- GUARDIX-FL / Genewel1301
- Conditions
- Genital Diseases, Female
- Keywords
- cystectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Genewel Co., LtdIndustry (pharma, biotech, devices)
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 27 Mar 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.
- Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma)
- Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)
- Primary Outcome Measure : Anti-adhesion Rate
- Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GUARDIX-FL | Experimental | Device: Guardix-FLPatients will be treated with 1 or 2 sheet of GUARDIX-FL after ovarian cystectomy(Operative Day). |
| Interceed | Active comparator | Device: InterceedPatients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day). |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patients who sign the written informed consent
- Women aged between 18 and 44
- The patients who are able to participate in clinical trial during the period of study
- The patients without abnormal figures at the screening laboratory examination
- The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma)
Key exclusion criteria (9 listed)
- The patients who took treatments with medical products which might be barrier to evaluate the effectiveness
- The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants
- The patients with severe drug allergy
- The patients with infectious disease on abdominal or pelvic cavity
- The patients who previously participated in another clinical trials within the past 30 days
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 |
|---|---|---|
| Guardix-FL | Device | GUARDIX-FL |
| Interceed | Device | Interceed |
Primary outcome
Anti-Adhesion Rate
Time frame: Post-Operative Day+4weeks(Second - look)
Adhesion yes or no
1 secondary outcome
Score
Time frame: Post-Operative Day+4weeks(Second-look)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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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.
Joong Sub Choi, Ph.D study director
Hanyang University Seoul Hospital
Seong Hun Kim, Ph.D principal investigator
Severance Hospital
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 Guardix-FL and Interceed in people with Genital Diseases, Female, run by Genewel Co., Ltd 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 5 inclusion and 9 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 27 Mar 2014. 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 Jun Ho Kim, Master (82-10-6455-3455, junho1012@idongsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Adhesion Rate (time frame: Post-Operative Day+4weeks(Second - look)). 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 27 Mar 2014.