A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Keloid Scars.

NCT03693924 | Unknown FDA Device

• 1 other identifier: SRTS-SRT-002
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Keloid formation in response to skin trauma inflicts about 18 million individuals. A key impediment in successful treatment of keloids is that the predominant treatments, particularly surgical excision and shaving, tend to initiate the regrowth of the keloid at the excision site, and therefore, recurrence rates are high. There is much evidence to demonstrate that following surgical excision procedures with a course of radiation therapy can significantly reduce recurrence rates to as little as 10% or below. This retrospective study is to evaluate this claim.

Conditions

Keloid Scar

Outcome Measures

Primary Outcomes (1)

• Long-term recurrence rate

  Recurrence rate will be calculated as the percentage of keloids that recurred at the treatment site following treatment completion.

  one year

Interventions

SRT-100 RADIATION

The SRT-100™ is a simple painless non-invasive in-office procedure that is approved by the U.S. Food and Drug Administration (U.S. FDA) to treat keloids caused by surgery or injury by delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) that only goes skin deep.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises patients who were treated with the SRT-100™ for one or more recurrent keloids and who have at least 1 year of follow-up data.

You may qualify if:

• Confirmed diagnosis of keloid(s).
• Treatment with SRT-100™ of one or more keloids.
• At least 1 year since treatment end.
• Required retrospective data is existing and sufficient.

You may not qualify if:

• Lesions of etiology other than keloids.

Sponsors & Collaborators

• Sensus Healthcare: lead

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian Berman, M.D.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Raymond

CONTACT

561.922.5808; iraymond@sensushealthcare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: November 15, 2018
• Primary Completion: February 16, 2019
• Study Completion: February 16, 2019
• Last Updated: October 3, 2018

Record last verified: 2018-10