None listed
Conditions
Brief summary
The aim of the NODULE study is to assess the safety, efficacy and feasibility of the Prana System for the sampling of small pulmonary (lung) nodules that are suspected of being cancerous. Who is it for? You may be eligible for this study if you are aged between 40 and 75 years and you have a lung nodule that is suspected of being cancerous. Study details All participants who choose to enrol in this study will undergo an initial nodule localisation procedure which involves having their with a localisation wire placed through the lung nodule (under local anaesthesia) during a CT scan. Once the wire has been inserted, participants will then be moved to an operating room where a thoracic surgeon will use the Prana System to take a piece of tissue from the area around the lung nodule. All participants will then be managed as per standard of care for thoracic (chest) surgery and will be asked to stay in hospital for at least 24 hours after the procedure. All participants will then be followed up during their hospital stay and at 14 and 30 days after completion of the procedure. It is hoped this research will determine whether use of the novel Prana system is safe and feasible for use in patients with a lung nodule that requires biopsy to assess if it is cancerous. If the Prana System is found to be safe and effective for biopsy of suspected cancer nodules, there may be scope for further use in the future.
Interventions
Phase 1 of Procedure: Subjects enrolled in the study will have a Prana Surgical localisation wire placed in their lung nodule during a procedure performed by an interventional radiologist in a CT guided procedure (in an interventional radiology suite). It is anticipated that the wire localisation procedure will take approximately 30 minutes. Only one single nodule will be localised / targeted in each subject.
Phase 2 of Procedure: Subjects will then be transferred to an operating theatre wher
Phase 1 of Procedure: Subjects enrolled in the study will have a Prana Surgical localisation wire placed in their lung nodule during a procedure performed by an interventional radiologist in a CT guided procedure (in an interventional radiology suite). It is anticipated that the wire localisation procedure will take approximately 30 minutes. Only one single nodule will be localised / targeted in each subject. Phase 2 of Procedure: Subjects will then be transferred to an operating theatre where a thoracic surgeon will utilise the Prana Surgical system to remove tissue around the lung nodule for pathological evaluation. In this phase of the procedure subjects will be under general anaesthesia and mechanically ventilated. It is anticipated that the Prana Surgical procedure will take approximately one hour. The Prana System involves an over the wire device that is used to create a tract from the skin to the tissue in the region of the nodule. The Prana device is deployed over the wire and a short burst of radiofreqency energy is used to excise the tissue in the area of the nodule. The localisation wire is removed once the Prana system is deployed within the region of the nodule. The intervention will be assessed by determination of the surgeon of successful removal of tissue surrounding the nodule and usability of the Prana System according to key aspects to device performance. The cardiothoracic surgeons who perform the procedure will be trained by suitably qualified representatives of the sponsor prior to the first cases being performed. Following the removal of the tissue surrounding the lung nodule tissue will undergo histopathological evaluation for the presence of malignant cells. if it is deemed necessary, the procedure may be converted to a thoracic surgical resection where the lung nodule is removed. The Prana component of the procedure is determined as being completed when the tissue that is sin the region of the nodule is removed within the Prana system, Subjects will be transferred to the Post Anaesthesia Care Unit where they will be monitored as per standard of care thoracic surgery. Overnight stay (one night minimum) is mandated.
Sponsors
Prana Thoracic Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
All participants eligible to be entered into the study must meet all the following criteria: 1. Age greater than 50 years of age and less than or equal to 75 years old 2. Demonstrated lung nodule in the periphery of the lung (defined as within 3 cm of the pleural surface) determined to be accessible by the Prana System 3. Confirmed surgical candidacy 4. Participant is willing and able to comply with all aspects of the treatment and evaluation schedule 5. Signed informed consent
Exclusion criteria
Participants that meet any of the following criteria will be ineligible for this study: 1. Prolonged chest infection, defined as lung consolidation that requires hospitalisation and greater than 10 days of antibiotics 30 days prior to surgery 2. Bullous emphysema in the anticipated tissue resection track 3. Known bleeding diathesis 4. Kidney dysfunction requiring dialysis (KDRD) 5. Extensive interstitial lung disease (ILD) 6. Pregnant or actively breastfeeding 7. Past surgical history that includes ipsilateral lung or pleural surgery 8. Current or planned enrollment in an interventional clinical trial with an investigational drug or device within 30 days 9. Any secondary condition or anatomical constraints as determined by the investigator that would place the participant at an increased risk or preclude the participant’s full compliance with the study procedures (e.g., chest wall deformity or excessive chest wall thickness)
Outcome results
None listed