Chronic Obstructive Pulmonary Disease (COPD)UAV-LUNGNCT07790822
Cross-Regional Unmanned Aircraft Transport of Donor Lungs
A study testing Cross-Regional Unmanned Aircraft Transport of Donor Lungs in people with Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Disease (ILD), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), End-stage Lung Disease
- What is being tested?
- Cross-Regional Unmanned Aircraft Transport of Donor Lungs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 packaged donor lung does not meet aircraft or transport-container requirements for weight, dimensions, fixation, packaging, or preservation.
- The participant is younger than 18 years.
- The participant is planned for combined heart-lung transplantation, another multi-organ transplantation, or repeat lung transplantation.
- 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.
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- The participant or legally authorized representative declines participation or valid informed consent cannot be obtained.
- Before task activation, weather, airspace, route, landing site, aircraft, propulsion, navigation, communication, monitoring, or energy-reserve conditions fail to meet prespecified operational criteria.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangzhou Medical University, Datansha Campus
Guangzhou, Guangdong, 510163
Jiaqin Zhang, 13662833144, zhang_jqwow@163.com
About this study
Official title: Feasibility and Timeliness of Cross-Regional Unmanned Aircraft Transport of Donor Lungs: A Prospective Single-Arm Clinical Study
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.
Read the detailed description
The study will be conducted between the Second Affiliated Hospital of Guangxi Medical University in Nanning, the donor-lung transport origin, and the First Affiliated Hospital of Guangzhou Medical University, Datansha Campus, the receiving and transplant center. The planned route is approximately 570 km. The study does not include a concurrent physical ground-transport arm. For each activated task, real-time estimated arrival times for ground transport will be obtained from two prespecified map platforms at the same origin, destination, and reference time. These estimates are an external task-level benchmark for transport efficiency and will not be interpreted as a randomized or parallel clinical control.
Each formally activated task is the primary operational unit of analysis. A bilateral donor-lung shipment intended for one recipient is counted as one task. After clinical acceptance of the donor lung and confirmation of participant eligibility, the lung will undergo standard perfusion, cold preservation, triple sterile packaging, identity verification, and loading into a validated transport container. The unmanned aircraft will fly an approved route under continuous flight and environmental monitoring. A ground backup transport plan will remain available. If medical, weather, airspace, aircraft, communication, energy, or landing-site conditions become unacceptable, the task may be delayed, canceled, returned, diverted, or transferred to ground transport. All activated tasks, including tasks that do not take off or do not complete unmanned transport, will remain in the transport-task analysis set.
The primary outcome is actual door-to-door donor-lung transport time, calculated in minutes from the time the lung exits the donor operating room (T1) to the time it enters the recipient operating room (T6). Key secondary outcomes include the proportion of activated tasks completed successfully, absolute and relative time gain versus contemporaneous ground-transport estimates, lung preservation and ischemic times, temperature stability, vibration and shock, pressure change, communication-link availability, packaging integrity, and donor-lung utilization. Recipients who undergo transplantation with a study-transported donor lung will be evaluated for primary graft dysfunction, perioperative complications, intensive care and hospital length of stay, graft survival, and participant survival through postoperative day 90.
Donor-lung acceptance, recipient selection, transplantation, and postoperative treatment will follow routine clinical standards and will remain independent of study efficiency targets. Prespecified pause rules include any catastrophic transport event, loss or non-recovery of the donor lung, a clearly transport-related organ discard, a serious aviation accident, or a participant death considered clearly or highly likely related to the transport intervention.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), End-stage Lung Disease
- Being tested
- Cross-Regional Unmanned Aircraft Transport of Donor Lungs
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-Regional Unmanned Aircraft Transport of Donor LungsOther
After clinical acceptance and standard donor-lung preservation, the packaged donor lung will be placed in a dedicated transport container and carried by a long-range vertical-takeoff-and-landing unmanned aircraft along an approved cross-regional route. The task includes identity verification, loading, monitored flight, unloading, medical handover, and transfer to the recipient operating room. Temperature, three-axis acceleration, pressure, humidity, position, communication, and aircraft operating parameters will be recorded. A predefined backup transport plan and task cancellation, return, diversion, and ground-relay procedures will be available throughout the task.
| Study group | Role | What they receive |
|---|---|---|
| Unmanned Aircraft Donor Lung Transport | Experimental | Participants in this single study arm are adult lung transplant candidates whose allocated donor lung will undergo standard perfusion, cold preservation, triple sterile packaging, and transport from Nanning to Guangzhou by a long-range unmanned aircraft system. Flight and donor-lung transport conditions will be continuously monitored. Donor-lung acceptance, transplantation, and postoperative care will follow routine clinical standards. Receives: Other: Cross-Regional Unmanned Aircraft Transport of Donor Lungs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual Door-to-Door Donor Lung Transport Time
Actual door-to-door transport time will be calculated in minutes as T6 minus T1. The interval includes donor-hospital internal transfer, loading and handover, any pre-takeoff waiting after T1, flight, unloading, recipient-hospital handover, and internal transfer to the recipient operating room. Synchronized electronic timestamps will be used preferentially; a jointly verified manual record will be used if automated sources fail.
Measured: During each transport task, from donor operating room exit (T1) to recipient operating room entry (T6)
Secondary outcomes (4)
Absolute Time Gain Compared With Contemporaneous Ground-Transport Estimate
For each of two prespecified map platforms, absolute time gain will be calculated in minutes as the platform-specific contemporaneous ground-transport estimated duration minus the actual unmanned-aircraft door-to-door transport time. Results from the two platforms will be reported separately; a positive value indicates time saved.
Measured: At completion of each donor-lung transport task (recipient operating room entry, T6)
Cold Preservation Time of the First Implanted Lung
Cold preservation time for the first implanted lung will be calculated in minutes as T7a0 minus T0. For single-lung transplantation, the implanted lung will be analyzed as the first implanted lung.
Measured: From the start of cold perfusion (T0) to the end of cold preservation for the first implanted lung (T7a0)
Cold Preservation Time of the Second Implanted Lung
For bilateral lung transplantation, cold preservation time for the second implanted lung will be calculated in minutes as T7b0 minus T0. This outcome is not applicable to single-lung transplantation.
Measured: From the start of cold perfusion (T0) to the end of cold preservation for the second implanted lung (T7b0)
Graft Survival at 30 Days
The proportion of transplanted participants alive with a functioning transplanted lung and without retransplantation at postoperative day 30 will be reported.
Measured: 30 days after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of adult lung transplant candidates will receive donor lungs transported by a standardized cross-regional unmanned aircraft system. There is no parallel clinical control arm. Contemporaneous ground-transport estimates are used only as task-level time benchmarks.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790822
- Sponsor's protocol ID
- UAV-LUNG-001
- Acronym
- UAV-LUNG
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Timeliness of Cross-Regional Unmanned Aircraft Transport of Donor Lungs: A Prospective Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07790822
- Acronym / sponsor ID
- UAV-LUNG / UAV-LUNG-001
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), End-stage Lung Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted between the Second Affiliated Hospital of Guangxi Medical University in Nanning, the donor-lung transport origin, and the First Affiliated Hospital of Guangzhou Medical University, Datansha Campus, the receiving and transplant center. The planned route is approximately 570 km. The study does not include a concurrent physical ground-transport arm. For each activated task, real-time estimated arrival times for ground transport will be obtained from two prespecified map platforms at the same origin, destination, and reference time. These estimates are an external task-level benchmark for transport efficiency and will not be interpreted as a randomized or parallel clinical control.
Each formally activated task is the primary operational unit of analysis. A bilateral donor-lung shipment intended for one recipient is counted as one task. After clinical acceptance of the donor lung and confirmation of participant eligibility, the lung will undergo standard perfusion, cold preservation, triple sterile packaging, identity verification, and loading into a validated transport container. The unmanned aircraft will fly an approved route under continuous flight and environmental monitoring. A ground backup transport plan will remain available. If medical, weather, airspace, aircraft, communication, energy, or landing-site conditions become unacceptable, the task may be delayed, canceled, returned, diverted, or transferred to ground transport. All activated tasks, including tasks that do not take off or do not complete unmanned transport, will remain in the transport-task analysis set.
The primary outcome is actual door-to-door donor-lung transport time, calculated in minutes from the time the lung exits the donor operating room (T1) to the time it enters the recipient operating room (T6). Key secondary outcomes include the proportion of activated tasks completed successfully, absolute and relative time gain versus contemporaneous ground-transport estimates, lung preservation and ischemic times, temperature stability, vibration and shock, pressure change, communication-link availability, packaging integrity, and donor-lung utilization. Recipients who undergo transplantation with a study-transported donor lung will be evaluated for primary graft dysfunction, perioperative complications, intensive care and hospital length of stay, graft survival, and participant survival through postoperative day 90.
Donor-lung acceptance, recipient selection, transplantation, and postoperative treatment will follow routine clinical standards and will remain independent of study efficiency targets. Prespecified pause rules include any catastrophic transport event, loss or non-recovery of the donor lung, a clearly transport-related organ discard, a serious aviation accident, or a participant death considered clearly or highly likely related to the transport intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of adult lung transplant candidates will receive donor lungs transported by a standardized cross-regional unmanned aircraft system. There is no parallel clinical control arm. Contemporaneous ground-transport estimates are used only as task-level time benchmarks.
| Arm | Type | Receives |
|---|---|---|
| Unmanned Aircraft Donor Lung Transport | Experimental | Other: Cross-Regional Unmanned Aircraft Transport of Donor LungsParticipants in this single study arm are adult lung transplant candidates whose allocated donor lung will undergo standard perfusion, cold preservation, triple sterile packaging, and transport from Nanning to Guangzhou by a long-range unmanned aircraft system. Flight and donor-lung transport conditions will be continuously monitored. Donor-lung acceptance, transplantation, and postoperative care will follow routine clinical standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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 packaged donor lung does not meet aircraft or transport-container requirements for weight, dimensions, fixation, packaging, or preservation.
- The participant is younger than 18 years.
- The participant is planned for combined heart-lung transplantation, another multi-organ transplantation, or repeat lung transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-Regional Unmanned Aircraft Transport of Donor LungsAfter clinical acceptance and standard donor-lung preservation, the packaged donor lung will be placed in a dedicated transport container and carried by a long-range vertical-takeoff-and-landing unmanned aircraft along an approved cross-regional route. The task includes identity verification, loading, monitored flight, unloading, medical handover, and transfer to the recipient operating room. Temperature, three-axis acceleration, pressure, humidity, position, communication, and aircraft operating parameters will be recorded. A predefined backup transport plan and task cancellation, return, diversion, and ground-relay procedures will be available throughout the task. | Other | Unmanned Aircraft Donor Lung Transport |
Primary outcome
Actual Door-to-Door Donor Lung Transport Time
Time frame: During each transport task, from donor operating room exit (T1) to recipient operating room entry (T6)
Actual door-to-door transport time will be calculated in minutes as T6 minus T1. The interval includes donor-hospital internal transfer, loading and handover, any pre-takeoff waiting after T1, flight, unloading, recipient-hospital handover, and internal transfer to the recipient operating room. Synchronized electronic timestamps will be used preferentially; a jointly verified manual record will be used if automated sources fail.
4 secondary outcomes
Absolute Time Gain Compared With Contemporaneous Ground-Transport Estimate
Time frame: At completion of each donor-lung transport task (recipient operating room entry, T6)
Cold Preservation Time of the First Implanted Lung
Time frame: From the start of cold perfusion (T0) to the end of cold preservation for the first implanted lung (T7a0)
Cold Preservation Time of the Second Implanted Lung
Time frame: From the start of cold perfusion (T0) to the end of cold preservation for the second implanted lung (T7b0)
Graft Survival at 30 Days
Time frame: 30 days after lung transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-Regional Unmanned Aircraft Transport of Donor Lungs in people with Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Disease (ILD), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaqin Zhang, M.D. (13662833144, zhang_jqwow@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual Door-to-Door Donor Lung Transport Time (time frame: During each transport task, from donor operating room exit (T1) to recipient operating room entry (T6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.