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9. Clinical trials

  • On March 1, 2023
  • COVE Study (based in Melbourne)

COVE Study participants must:

Have a diagnosis of severe or very severe emphysema.

Be aged 40 years and over.

Be willing and able to provide informed consent to participate in the study.

If you meet all of the criteria above, speak to your general practitioner or specialist and request a referral to the study site or selected hospital in your local state for consideration to participate in the study. Please find the trial site list here: https://covestudy.com.au/trial-sites/

Your doctor will be able to access the COVE Study suitability criteria directly from our website – covestudy.com.au/faqs.

If you would like a hard copy of this information posted, or if you would like us to contact your doctor directly on your behalf, please let us know your postal address or doctor’s contact details here.

Clinicians and patients wishing to learn more or to register their interest in the COVE Study, can visit covestudy.com.au or info@covestudy.com.au

Website: covestudy.com.au

Phone: 03 9419 2477

Email: info@covestudy.com.au

  • CONVERT Trial (Sydney based)

Brief Summary:

This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages:

Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments.

Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.

Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR).

Clinical assessments will be conducted at 45 Days, 3 and 6-months post-Zephyr Valve procedure.

Website https://clinicaltrials.gov/ct2/show/NCT04559464

Location and contact:

Macquarie University Hospital Recruiting
Sydney, Australia
Contact: Alvin Ing, MD       alvin.ing@mq.edu.au
Principal Investigator: Alvin Ing, MD

 

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