This report covers a phase II prospective study evaluating the Maastro Applicator HDR brachytherapy for rectal cancer, led by Siriraj Hospital, with recruitment not yet underway.
What changed
Trial status
The information describes a phase II prospective trial of rectal HDR brachytherapy using the Maastro Applicator. The sponsor is Siriraj Hospital, and the intervention is a rectal high dose rate brachytherapy procedure performed with the Maastro Applicator. The record notes the trial status as not yet recruiting and provides the ClinicalTrials.gov identifier NCT07402486.
How the study is designed
Design details
The study is described as phase II and prospective. It aims to evaluate therapy using a Maastro Applicator for rectal cancer. Details such as inclusion criteria, sample size, endpoints, or follow up plan are not provided in the source text. The record confirms the intervention type as rectal HDR brachytherapy with a Maastro Applicator and identifies Siriraj Hospital as sponsor.
Regulatory context and device use
The Maastro Applicator serves as the delivery device for rectal high dose rate brachytherapy in this trial. The record does not provide safety or efficacy claims beyond the trial framework. The sponsor is Siriraj Hospital, and the ClinicalTrials.gov reference remains NCT07402486. The not yet recruiting status signals ongoing regulatory and site readiness steps before enrollment begins.
Regulatory alignment
Future progress will require compliance with good clinical practice and applicable local requirements. The information in this piece is intended to inform regulatory stakeholders about the trial plan and device use rather than to present final performance data.
Safety and intended use
Intended use
The intended use described here is rectal high dose rate brachytherapy delivered with the Maastro Applicator. Safety considerations and performance expectations will be evaluated as part of the phase II trial. Readers should treat these notes as disclosures tied to a research protocol rather than confirmed device claims.
FAQ
- 1. What is Maastro Applicator HDR brachytherapy?
The term refers to a rectal high dose rate brachytherapy procedure performed with the Maastro Applicator as described in the trial record. - 2. Who sponsors the study?
Siriraj Hospital is listed as the sponsor for this phase II prospective trial. - 3. What is the recruitment status?
The record states not yet recruiting, indicating that patient enrollment has not started. - 4. Where can I find more information?
The trial is registered on ClinicalTrials.gov under identifier NCT07402486, and the provided link is included below.
Conclusion
The phase II prospective study of the Maastro Applicator HDR brachytherapy for rectal cancer marks an early regulatory and research step. The available facts confirm the device name, the intervention type, the sponsor and the recruitment status. Stakeholders including clinicians and trial sponsors may watch for updates on enrollment endpoints and safety data as the study progresses.
Disclaimer
This article is intended for healthcare professionals and regulatory staff. It is not legal advice and does not replace guidance from regulatory bodies or institutional review boards. Always verify current trial status and official documents before making decisions.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07402486?term=medical+device