Completed

EURO KLEARA Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR

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What is being tested

Celotres

Device
Who is being recruted

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorHalscion, Inc.
Last updated: May 28, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.

NCT01706861
Principal SponsorHalscion, Inc.
Last updated: May 28, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Patients able and willing to give written informed consent
Patients electing to undergo keloid excision procedure
1 exclusion criteria prevent from participating
Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Celotres following surgical removal of earlobe keloid.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Angelius Szpital Proviat

Katowice, PolandOpen Angelius Szpital Proviat in Google Maps

Oddzial Leczenia Oparzen Chirugil Plastysznej

Krakow, Poland

Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"

Warsaw, Poland

Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej

Warsaw, Poland
Completed6 Study Centers