Skip to main content
OpenTrials
Completed

NCT Number: NCT01750112

Treatment of Pectus Excavatum Deformity Using Macrolane Filler

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pectus Excavatum Deformity Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Raphael Sinna, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Macrolane VRF20

Device

Injection treatment with Macrolane VRF20

Primary outcomes

  1. 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.

  2. Subject satisfaction

    Time frame: Jul 2016

    Evaluate subject satisfaction at 1, 3, 6, 12 and 24 months after treatment.

  3. 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).

  4. Placement

    Time frame: Jul 2016

    Assess placement using MRI at 1 and 12 months post treatment.

  5. 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.

  6. Downtime

    Time frame: Jul 2016

    Evaluate recovery time after treatment using 14-days subject diary.

  7. Downtime 2

    Time frame: Jul 2016

    Evaluate days hospitalized or on sick leave after treatment.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Collaborators

  • Pharma Consulting Group AB

Registry information

Official study title

An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2012
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.