Pectus Excavatum DeformityNCT01750112
Treatment of Pectus Excavatum Deformity Using Macrolane Filler
A study testing Macrolane VRF20 in people with Pectus Excavatum Deformity, run by Galderma R&D at 2 sites in 2 countries.
Trial summary
This is a prospective, open, non-comparative and baseline-controlled study to evaluate efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum deformity. Each subject participating in the study will be treated with approximately 50-150 ml of Macrolane VRF20. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pectus Excavatum Deformity
- What is being tested?
- Macrolane VRF20
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2012to Sep 2016
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give verbal and written informed consent to participate in the study.
- Be a healthy male of 18 years or more.
- Have a pectus excavatum deformity without functional problems; score 4 in items 10, 11 and 12 of the PEEQ, indicating there is no functional impairment due to the pectus excavatum deformation.
- Present normal cardiac function as assessed by ECG and echocardiogram.
- Present normal pulmonary function as assessed by pulmonary function test.
- Present a chest X-ray taken within 12 months prior to the baseline visit, without clinically significant defects to heart, lungs, skeleton, ribs, sternum or spinal cord except for the pectus excavatum defect, in the opinion of the Investigator.
- Have the ability to understand and comply with the requirements of the study.
Who cannot join
- Score 1, 2 or 3 in either of items 10, 11 and 12 of the PEEQ, indicative of functional problems due to the pectus excavatum deformity.
- Previous treatment for the same indication.
- Known or suspected hypersensitivity to hyaluronic acid based products.
- BMI < 20.
- A history of severe allergies manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies (as judged by the Investigator).
- Known allergy to any anesthesia planned during the study.
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- Presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the study.
- Subjects with bleeding disorders or subjects who are taking thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, including non-steroidal anti-inflammatory agents and acetylsalicylic acid, two weeks before treatment.
- Subjects on immunomodulatory therapy (suppressive or stimulatory).
- Subjects with contraindications for MRI, such as presence of pacemaker, clips or splinter, or tendency for claustrophobia.
- Any condition which in the opinion of the Investigator makes the subject unsuitable for inclusion (e.g., subjects not likely to participate for the duration of the study).
- Use of any investigational drugs or devices within 30 days prior to baseline.
- Subjects who are study site staff for this study, or close relatives of the study site staff, as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum
This is a prospective, open, non-comparative and baseline-controlled study to evaluate efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum deformity.
Each subject participating in the study will be treated with approximately 50-150 ml of Macrolane VRF20. The amount of study product used will be individually determined in order to achieve an optimal correction of the deformity in each subject.
- Conditions
- Pectus Excavatum Deformity
- Being tested
- Macrolane VRF20
- Keywords
- Pectus excavatum, funnel chest, sunken chest
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macrolane VRF20Device
Injection treatment with Macrolane VRF20
| Study group | Role | What they receive |
|---|---|---|
| Macrolane VRF20 | Experimental | All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity. Receives: Device: Macrolane VRF20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEEQ
To evaluate improvement from baseline in general self-esteem and emotion at 1, 3, 6, 12 and 24 months after treatment with Macrolane VRF20, using a modified version of the pectus excavatum evaluation questionnaire (PEEQ) before and after treatment.
Measured: Jul 2016
Subject satisfaction
Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment.
Measured: Jul 2016
Duration
Estimate duration of Macrolane VRF20 calculated using MRI images at 12 months (and 24 months for a subset of patients).
Measured: Jul 2016
Placement
Assess placement using MRI at 1 and 12 months post treatment.
Measured: Jul 2016
Adverse event
To study safety throughout the study period, i.e. up to 24 months after treatment, based on evaluation of reported Adverse Events.
Measured: Jul 2016
Downtime
Evaluate recovery time after treatment using 14-days subject diary.
Measured: Jul 2016
Downtime 2
Evaluate days hospitalized or on sick leave after treatment.
Measured: Jul 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus Excavatum DeformityStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharma Consulting Group AB
- Responsible party
- Sponsor
- Investigators
- Per Hedén, MD, PhD, Principal investigator, AkademiklinikenRaphael Sinna, MD, PhD, Principal investigator, University Hospital of Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750112
- Sponsor's protocol ID
- 31GC1201
- Status last verified
- May 2017
- First submitted
- 12 Dec 2012
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum
- ClinicalTrials.gov ID
- NCT01750112
- Acronym / sponsor ID
- 31GC1201
- Conditions
- Pectus Excavatum Deformity
- Keywords
- Pectus excavatum, funnel chest, sunken chest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Collaborators
- Pharma Consulting Group AB
- Study start
- Dec 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Dec 2012 (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 is a prospective, open, non-comparative and baseline-controlled study to evaluate efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum deformity.
Each subject participating in the study will be treated with approximately 50-150 ml of Macrolane VRF20. The amount of study product used will be individually determined in order to achieve an optimal correction of the deformity in each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macrolane VRF20 | Experimental | Device: Macrolane VRF20All subjects will receive treatment with Macrolane VRF20 to correct pectus excvatum deformity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Give verbal and written informed consent to participate in the study.
- Be a healthy male of 18 years or more.
- Have a pectus excavatum deformity without functional problems; score 4 in items 10, 11 and 12 of the PEEQ, indicating there is no functional impairment due to the pectus excavatum deformation.
- Present normal cardiac function as assessed by ECG and echocardiogram.
- Present normal pulmonary function as assessed by pulmonary function test.
Key exclusion criteria (13 listed)
- Score 1, 2 or 3 in either of items 10, 11 and 12 of the PEEQ, indicative of functional problems due to the pectus excavatum deformity.
- Previous treatment for the same indication.
- Known or suspected hypersensitivity to hyaluronic acid based products.
- BMI < 20.
- A history of severe allergies manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies (as judged by the Investigator).
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 |
|---|---|---|
| Macrolane VRF20Injection treatment with Macrolane VRF20 | Device | Macrolane VRF20 |
Primary outcome
PEEQ
Time frame: Jul 2016
To evaluate improvement from baseline in general self-esteem and emotion at 1, 3, 6, 12 and 24 months after treatment with Macrolane VRF20, using a modified version of the pectus excavatum evaluation questionnaire (PEEQ) before and after treatment.
Subject satisfaction
Time frame: Jul 2016
Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment.
Duration
Time frame: Jul 2016
Estimate duration of Macrolane VRF20 calculated using MRI images at 12 months (and 24 months for a subset of patients).
Placement
Time frame: Jul 2016
Assess placement using MRI at 1 and 12 months post treatment.
Adverse event
Time frame: Jul 2016
To study safety throughout the study period, i.e. up to 24 months after treatment, based on evaluation of reported Adverse Events.
Downtime
Time frame: Jul 2016
Evaluate recovery time after treatment using 14-days subject diary.
Downtime 2
Time frame: Jul 2016
Evaluate days hospitalized or on sick leave after treatment.
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 25 Aug 2022.
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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.
Per Hedén, MD, PhD principal investigator
Akademikliniken
Raphael Sinna, MD, PhD principal investigator
University Hospital of Amiens
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macrolane VRF20 in people with Pectus Excavatum Deformity, run by Galderma R&D at 2 sites in 2 countries.
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 7 inclusion and 13 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Sweden. 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.
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?
PEEQ (time frame: Jul 2016). The study lists 7 primary outcomes in all. 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 25 Aug 2022.