NCT06869122Toboroz
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 21.
Rövid összefoglaló (regiszter, angolul)
This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). In this study, the investigators are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours. The aim of this study is to evaluate the safety and performance of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional procedure to their surgical procedure. The study, funded by Creo Medical, will be conducted at sites in the UK and Italy, and will involve up to 18 participants.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 18 (tervezett)
- Első benyújtás
- 2025. márc. 5.
- Kezdés
- 2025. júl. 14.
- Elsődleges befejezés
- 2026. nov.
- Fő szponzor
- Creo Medical Limited
- Betegségek
- Tüdőrák
- NCT-szám
- NCT06869122
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 18
- 2025. júl. 14. és az elsődleges befejezés (2026. nov.) között
- 2 helyszín, 2 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
- Have an implantable device, including pacemakers or other electronic implants.
- Subject had a prior pneumonectomy.
- Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.
Más betegség
- Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic \& laryngeal nerves).
- Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
- Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] >50mmHg).
- Diagnosis of Small Cell Lung Cancer.
Egyéb
- Patients who:
- Are pregnant or breast feeding, as determined by standard site practices.
- Have an expected survival less than 12 months.
- Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
Kiket keres a vizsgálat
- Patients who:
- Have signed informed consent.
- Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- Are ≥ 18 years old.
- Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer.
- Have soft tissue lung lesion(s):
- ≤ 20 mm in the largest dimension of the pulmonary window
- Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
- > 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
- Subject is willing and able to comply with the study protocol requirements.
- Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street | London | Egyesült Királyság | Toboroz |
| Istituto Europeo di Oncologia (IEO), Via Ripamonti 435 | Milan | Olaszország | Toborzás még nem indult |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.