Laparoscopic MyomectomyPhase 3NCT01810900
To Assess the Anti-adhesive Effect and Safety of Protescal
A Phase 3 study testing Protescal in people with Laparoscopic Myomectomy, run by LG Life Sciences at 1 site in South Korea.
Trial summary
This multicenter, randomized, single-blind study assessed the safety and efficacy of Protescal for the reduction of post-operative adhesion formation following myomectomy. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Laparoscopic Myomectomy
- What is being tested?
- Protescal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Dec 2013
- 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
- a woman who is over 20 years old
- a woman who needs a laparoscopic myomectomy
Who cannot join
- a pregnant woman and a nursing mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery
This multicenter, randomized, single-blind study assessed the safety and efficacy of Protescal for the reduction of post-operative adhesion formation following myomectomy.
Read the detailed description
The age of the patients participating in the study overed 20 years and included nonpregnant women requiring laparoscopic myomectomy and expected to undergo a second-look laparoscopy as part of their treatment plan 5 weeks after the initial surgery.
- Conditions
- Laparoscopic Myomectomy
- Being tested
- Protescal
- Keywords
- anti-adhesive effect and safety, laparoscopic myomectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtescalDevice
| Study group | Role | What they receive |
|---|---|---|
| Protescal | Experimental | Protescal is applied to this arm. Receives: Device: Protescal |
| non-treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence/absence of postoperative adhesions at second-look procedure
Measured: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic MyomectomyStudies 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
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810900
- Sponsor's protocol ID
- LG-ABCL002
- Status last verified
- Nov 2014
- First submitted
- 12 Mar 2013
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01810900
- Acronym / sponsor ID
- LG-ABCL002
- Conditions
- Laparoscopic Myomectomy
- Keywords
- anti-adhesive effect and safety, laparoscopic myomectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Mar 2013 (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.
This multicenter, randomized, single-blind study assessed the safety and efficacy of Protescal for the reduction of post-operative adhesion formation following myomectomy.
Detailed description
The age of the patients participating in the study overed 20 years and included nonpregnant women requiring laparoscopic myomectomy and expected to undergo a second-look laparoscopy as part of their treatment plan 5 weeks after the initial surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protescal | Experimental | Device: ProtescalProtescal is applied to this arm. |
| non-treatment | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a woman who is over 20 years old
- a woman who needs a laparoscopic myomectomy
Key exclusion criteria (1 listed)
- a pregnant woman and a nursing mother
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 |
|---|---|---|
| Protescal | Device | Protescal |
Primary outcome
presence/absence of postoperative adhesions at second-look procedure
Time frame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Protescal in people with Laparoscopic Myomectomy, run by LG Life Sciences 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Mar 2016. 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?
The study was stopped early. Results are not available in the source record.
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?
presence/absence of postoperative adhesions at second-look procedure (time frame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy). 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 11 Mar 2016.