This one surprised me but it seems the device is registered in...

This one surprised me but it seems the device is registered in hong kong and now they are working on trial which is positive step. As per my previous post about Hong Kong Approval the device registration last for 5 years and this trail below if successful will give validation to safety and usefulness of the device in down staging tumor.

Good luck all holders... !

Abstract from trial submission below.

Sponsor:

Chinese University of Hong Kong

Information provided by (Responsible Party):

Anthony Teoh, Chinese University of Hong Kong

Study Description

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Brief Summary:

The outcomes of concurrent EUS-guided intra-tumour injection of P-32 microparticles (OncoSil;OncoSilMedical, Australia) with chemotherapy in locally advanced pancreatic carcinoma in the local population is uncertain.

The aim of the current study is to assess efficacy and safety of the intervention in the local population. We hypothesis that the intervention is safe and useful for tumour downstaging.

	Condition or disease	Intervention/treatment	Phase
1	Pancreatic CancerEndoscopic Ultrasound	Device: EUS-guidedoncosilinjection	Phase 2Phase 3

Detailed Description:

This would be a cohort study including patients with locally advanced pancreatic cancer medically fit to receive chemotherapy. Eligible patients would receive gemcitabine (GNP; 28- day cycles). P-32 microparticles (OncoSil; OncoSil Medical) implantation will be planned at weeks 4-5. P-32 activity will be calculated from patients' tumor volume (TV) to deliver 100 Gy absorbed dose, with implantation assessment by EUS and Bremsstrahlung SPECT/CT imaging. The primary endpoint was safety and tolerability, graded using CTCAE v4.0. Response will be assessed using RECIST 1.1 with 8-weekly CT scans and FDG-PET scans at baseline and week 12. The outcome parameters include adverse events, response of the tumour, local progression free survival and overall survival (OS).

Study Design

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	Study Type:	Interventional (Clinical Trial)
1	EstimatedEnrollment:	20 participants
2	Allocation:	N/A
3	Intervention Model:	Single Group Assignment
4	Intervention Model Description:	OncoSil™ is comprised of OncoSil Phosphorous-32 Microparticles (hereafter Microparticles) and OncoSil Diluent (hereafter Diluent). OncoSil™ is an active implantable (radiological) medical device intended for use in brachytherapy, where cancer is treated by the insertion of radioactive implants directly into the cancerous tissue. OncoSil™ has been designed to be injected directly into, and to deliver an average absorbed dose of 100 Gy to the target treatment tumour. In therapeutic use 98% of the radiation is delivered within 81 days.
5	Masking:	None (Open Label)
6	Primary Purpose:	Treatment
7	Official Title:	Concurrent EUS-guided Intra-tumour Injection ofOncoSil(32P) With Chemotherapy in Locally Advanced Pancreatic Carcinoma.
8	ActualStudy Start Date:	November 1, 2021
9	EstimatedPrimary Completion Date:	October 31, 2024
10	EstimatedStudy Completion Date:	October 31, 2024