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Treatment of Pectus Excavatum Deformity Using Macrolane Filler

NCT01750112 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-08-25

No results posted yet for this study

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. 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

Interventions

DEVICE

Macrolane VRF20

Injection treatment with Macrolane VRF20

Sponsors & Collaborators

  • Pharma Consulting Group AB

    collaborator INDUSTRY

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Per Hedén, MD, PhD · Akademikliniken

  • Raphael Sinna, MD, PhD · University Hospital of Amiens

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • France
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01750112 on ClinicalTrials.gov