Superficial Radiation Therapy (SRT) for the Treatment of Recurrent Keloid Scars

NCT04184011 | Unknown FDA Device

• 1 other identifier: SRTS-SRT-003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 prospective study is to evaluate this claim.

Conditions

Keloid Scar

Keywords

Superficial Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of keloid recurrence rates.

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

  2 years

Study Arms (1)

SRT for keloid scars

Individuals who are voluntarily scheduled to be treated at one of the participating study sites with SRT (SRT-100™, SRT-Vision™ or SRT-100+™) for the treatment of one or more recurrent keloids.

Device: SRT-100™

Interventions

SRT-100™ DEVICE

SRT delivers a precise, calibrated dose of radiotherapy following surgical excision for large and more difficult-to-treat keloids that cannot otherwise be treated by or have failed more conservative measures.

SRT for keloid scars

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises males and females of any age who are voluntarily scheduled to be treated with the SRT-100™, SRT-Vision™ or SRT-100+™ for one or more recurrent keloids.

You may qualify if:

• Confirmed diagnosis of keloid(s)
• Independently scheduled for treatment with SRT-100™, SRT-Vision™ or SRT-100+™ for one or more keloids
• Subject voluntary provides written consent to be in the study

You may not qualify if:

• Lesions of etiology other than keloids
• Any factor(s) that in the professional opinion of the investigator warrants the individual unsuitable for study participation

Sponsors & Collaborators

• Sensus Healthcare: lead

Study Sites (1)

Dermatology and Dermatological Surgery

Boynton Beach, Florida, 33437, United States

RECRUITING

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

• William I Roth, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Raymond

CONTACT

561-922-5808; iraymond@sensushealthcare.com

Study Design

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

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 3, 2019
• Study Start: August 15, 2019
• Primary Completion: August 16, 2020
• Study Completion: August 16, 2020
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)