NCT07790822Toborzás még nem indult
Cross-Regional Unmanned Aircraft Transport of Donor Lungs
Feasibility and Timeliness of Cross-Regional Unmanned Aircraft Transport of Donor Lungs: A Prospective Single-Arm Clinical Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 27.
Rövid összefoglaló (regiszter, angolul)
This prospective, single-arm study will evaluate the feasibility, timeliness, operational reliability, and preliminary safety of transporting donor lungs by a long-range unmanned aircraft system from Nanning to Guangzhou, China. Adult lung transplant candidates will be enrolled after a donor lung has been legally allocated and clinically accepted and after written informed consent has been obtained. Each formally activated transport task will use standard donor-lung perfusion and cold preservation, triple sterile packaging, and a dedicated transport container with continuous monitoring of temperature, vibration, pressure, position, and communication status. The primary outcome is the actual door-to-door transport time from the donor operating room exit to the recipient operating room entry. Secondary outcomes include transport success, time saved compared with contemporaneous ground-transport estimates, lung preservation and ischemic times, transport-environment performance, donor-lung condition on arrival, and early recipient and graft outcomes through 90 days after transplantation. Twenty-five participants corresponding to 25 formally activated donor-lung transport tasks are planned.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 25 (tervezett)
- Első benyújtás
- 2026. aug. 18.
- Kezdés
- 2026. szept. 1.
- Elsődleges befejezés
- 2027. szept. 1.
- Fő szponzor
- The First Affiliated Hospital of Guangzhou Medical University
- Betegségek
- Krónikus obstruktív tüdőbetegség (COPD)
- NCT-szám
- NCT07790822
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 25
- 2026. szept. 1. és az elsődleges befejezés (2027. szept. 1.) között
- 1 helyszín, 1 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
- The donor lung is considered unsuitable for transplantation or has been definitively declined before task activation.
- The donation, allocation, procurement, transport, or transplantation process does not comply with applicable legal, ethical, institutional, or protocol requirements.
- The participant is clinically unstable, the transplant procedure has been canceled or materially changed, or the transplant team considers the participant unsuitable to proceed with transplantation.
Más betegség
- The participant is planned for combined heart-lung transplantation, another multi-organ transplantation, or repeat lung transplantation.
- Before task activation, weather, airspace, route, landing site, aircraft, propulsion, navigation, communication, monitoring, or energy-reserve conditions fail to meet prespecified operational criteria.
Életkor
- The participant is younger than 18 years.
Egyéb
- The packaged donor lung does not meet aircraft or transport-container requirements for weight, dimensions, fixation, packaging, or preservation.
- The participant or legally authorized representative declines participation or valid informed consent cannot be obtained.
- A reliable backup transport plan cannot be established, or the study team determines that unmanned-aircraft transport would create an unacceptable risk of donor-lung loss, delay, contamination, or damage.
- Complete primary timestamps or key engineering parameters are not expected to be obtainable, or postoperative day-90 follow-up is not expected to be feasible.
- The investigator identifies another medical, ethical, operational, or safety reason that makes study participation inappropriate.
Kiket keres a vizsgálat
- The donor lung has been donated, allocated, procured, and assigned in accordance with applicable Chinese laws, regulations, allocation rules, and ethical requirements, and has been allocated to a lung transplant candidate at the First Affiliated Hospital of Guangzhou Medical University.
- The donor lung is considered clinically suitable for transplantation by both the procurement team and the recipient transplant team and is intended for single or bilateral lung transplantation.
- The donor-lung procurement location, transplant location, and transport route conform to the prespecified Nanning-to-Guangzhou cross-regional unmanned-aircraft scenario.
- After standard perfusion, cold preservation, and triple sterile packaging, the donor-lung package meets the transport-container and aircraft requirements for weight, dimensions, fixation, and preservation.
- The participant is 18 years of age or older, meets clinical indications for lung transplantation, and is considered medically suitable to undergo single or bilateral lung transplantation.
- The participant or legally authorized representative has provided written informed consent for the study before formal task activation.
- Before activation, the aircraft, propulsion, navigation, communication, monitoring equipment, landing sites, weather, airspace, route, energy reserve, and backup transport plan meet prespecified operational criteria.
- The main transport timestamps, environmental and flight-engineering data, and participant follow-up through postoperative day 90 are expected to be obtainable.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University, Datansha Campus Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Guangzhou | Kína | Ismeretlen állapot |
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