NCT05257486

Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx

A Post-market Multi-Center Retrospective-Prospective Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: Xoft, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this retrospective-prospective study is to evaluate lesions after treatment for BCC or SCC NMSC in order to gain a better understanding of the durability of the treatment, and risk of late toxicities for this patient population.

Detailed description

This is a retrospective-prospective study design. The study is post-market, on-label observational study for the treatment of NMSC. Patients who completed treatment at least five years from the last treatment will be identified and existing data as required by this protocol in the patient's record will be collected in addition to conducting office visits or telehealth visits (video) for long-term follow-up. The study will include: Identifying patients, retrospectively, who completed treatment a minimum of five years from the last treatment. The history and demographic data will be collected from up to 300 subjects previously treated with eBx for the treatment of NMSC. Patients will have an office visit or telehealth visit in order for the investigators to assess the lesion site, document absence of recurrence, treatment for recurrence (if applicable), and long-term toxicities at the time of the prospective visit.

Conditions

• Non-melanoma Skin Cancer

Interventions

Type	Name	Description
DEVICE	Xoft eBx	The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-07-18
• Completion: 2022-10-13
• First posted: 2022-02-25
• Last updated: 2025-01-13
• Results posted: 2025-01-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study