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Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears

NCT03194269 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-09-02

No results posted yet for this study

Summary

This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the long-term safety and performance of EARFOLD® Implantable Clip System.

Conditions

  • Prominent Ears

Interventions

DEVICE

EARFOLD®

EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • ALLERGAN INC. · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-17
Primary Completion
2021-09-07
Completion
2021-09-07

Countries

  • United Kingdom

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 NCT03194269 on ClinicalTrials.gov