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

NCT04184011 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-12-03

No results posted yet for this study

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

Interventions

DEVICE

SRT-100™

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.

Sponsors & Collaborators

  • Sensus Healthcare

    lead INDUSTRY

Principal Investigators

  • William I Roth, MD

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2020-08-16
Completion
2020-08-16
FDA Device
Yes

Countries

  • United States

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 NCT04184011 on ClinicalTrials.gov