A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Non-Melanoma Skin Cancer (NMSC)

NCT03693937 | Completed Results FDA Device

• 1 other identifier: SRTS-SRT-001
• Study Type: observational
• Target: 776
• Locations: 1 country
• Sites: 1

Brief Summary

Non-Melanoma Skin Cancer (NMSC) is the most commonly occurring type of skin cancer, and predominantly comprises (98%) Basal Cell Carcinomas (BCC) and Squamous Cell Carcinomas (SCC). About 3.3 million people in the United States (U.S.) are diagnosed with NMSC annually, equating about 5.4 million BCCs and SCCs. Low-dose Superficial Radiation Therapy (SRT) effectively destroys BCC and SCC without any invasive cutting, bleeding or stitching. There is no need for anesthesia, no risk of infection or scarring and no need for reconstructive plastic surgery. Healing time is quick with minimal to no post-treatment downtime or lifestyle restrictions. It is therefore both a viable and highly desirable alternative to invasive, painful and higher-risk surgical procedures. This study will utilize retrospective chart analysis to evaluate the outcomes of SRT-100™ therapy on NMSC lesions over a long-term post-treatment period.

Conditions

Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Cure Rate

  NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion.

  5 years

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
• 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 non-melanoma skin cancers (NMSCs) and have follow-up data.

You may qualify if:

• Treatment with SRT-100™.
• Treatment date of December 31, 2015 or earlier.
• Non-Melanoma Skin Cancer (NMSC) pathological diagnosis of confirmed squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).
• Histopathological Grade: G1 (well differentiated); G2 (moderately differentiated) or Gx (not assessed).
• One lesion is treated, or more than one lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins.
• Required retrospective data is existing and sufficient.

You may not qualify if:

• Lesions of etiology other than non-melanoma skin cancer (NMSC)

Sponsors & Collaborators

• Sensus Healthcare: lead

Study Sites (1)

Dermatology and Dermatological Surgery

Boynton Beach, Florida, 33437, United States

Location

Results Point of Contact

• Title: Isabelle Raymond
• Organization: Sensus Healthcare

iraymond@sensushealthcare.com

561-922-5808

Study Officials

• William Roth, M.D.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: March 16, 2019
• Study Completion: March 16, 2019
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)