Hospitalized PatientPhase 2PreDoPTINCT06902883
Study on the Effectiveness and Comfort of Innovative Solutions for the Internal Transport of Patients in Wheelchairs in a Hospital Setting
A Phase 2 study testing Serum holder connected to the wheelchair and wheelchair seat in people with Hospitalized Patient, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
In 2006, 2012, and 2018, under the auspices of the Pain Control Committee, Gustave Roussy stretcher-bearers conducted studies on patient pain caused by internal transport (stretchers). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Patient
- What is being tested?
- Serum holder connected to the wheelchair and wheelchair seat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2025to 19 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Informed patient and signed informed consent
- Age equal or greater than 18
- Speak and read french
- For serum holder connected to wheelchair only : patients with multiple infusion devices and transported in wheelchair
- For wheelchair seat : patients transported in wheelchair from hospitalized unit to radiology department
Who cannot join
- disoriented or confused patient
- Patients under judicial protection (curatorship, tutorship) and/or deprived of freedom
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
In 2006, 2012, and 2018, under the auspices of the Pain Control Committee, Gustave Roussy stretcher-bearers conducted studies on patient pain caused by internal transport (stretchers). The first study showed that this pain is primarily experienced by patients initially in pain, and that risk factors include crossing elevator landings and threshold bars, handling, and prolonged waiting times.
A progress plan was developed, and since 2006, improvement initiatives have been regularly implemented. Their effectiveness has been evaluated by patients and the professionals involved (departure department, carrier, and arrival department).
Read more
Stretcher-bearing software was purchased following the original study; scheduling has been streamlined, journeys are transmitted to stretcher-bearers via smartphones, and transport times are calculated and analyzed. In 2019, a prototype for connecting patients' IV poles to wheelchairs was developed and tested, thanks to a collaboration between technical services, stretcher-bearers, and the Bureau of Biostatistics and Epidemiology. The time spent by stretcher-bearers transferring infusion sets and other syringe pumps from the patient's IV pole to the wheelchair's pole on the way out, and vice versa on the way back to the room, has been eliminated. The hypothesis is that this elimination would reduce travel times and could have an indirect impact on reducing pain.
Wheelchair comfort has been continually improved since 2006: the front casters were replaced with softer and thicker ones, the rear wheels with soft wheels and then with pneumatic tires; the backrests were replaced with a memory foam model, and the seats with an "ultra-comfort" model. These improvements contribute to better pain management during transport and an improved patient experience. Wheelchair comfort could be further improved by replacing the seats with high-quality "Bultex" models.
In 2022, 33,800 patients were transported in wheelchairs (round trip, one-way or one-way), representing 35% of annual transports. Technical developments and improvements in wheelchair comfort could contribute to reducing pain caused by internal transport.
Primary Objective To evaluate the effect of two interventions (a system for connecting the IV pole to the wheelchair and a new seat) during the internal transport of cancer patients being treated at Gustave Roussy:
Intervention 1: To evaluate the impact of using the IV pole connection system on reducing the duration of wheelchair transport for patients receiving infusions; Intervention 2: To evaluate patient preference for the comfort of a wheelchair seat.
Secondary Objective To evaluate pain in transported patients (before/after)
- Conditions
- Hospitalized Patient
- Being tested
- Serum holder connected to the wheelchair, wheelchair seat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum holder connected to the wheelchairDevice
Serum holder connected to the wheelchair
wheelchair seatDevice
wheelchair seat
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair test 1 | Experimental | Patient will test experimental wheelchair during outward journey and standard wheelchair during return journey Receives: Device: Serum holder connected to the wheelchair; Device: wheelchair seat |
| Wheelchair test 2 | Experimental | Patient will test standard wheelchair during outward journey and experimental wheelchair during return journey Receives: Device: Serum holder connected to the wheelchair; Device: wheelchair seat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period of transportation
Unit of measurement: minute
Measured: 1 day
Comfort of the wheelchair
Comfort of the wheelchair evaluated according to satisfaction scale from 0 (uncomfortable) to 10 (very comfortable)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start16 Jun 2025
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902883
- Sponsor's protocol ID
- 2024-A00077-40/1
- Other IDs
- 2024/3801
- Acronym
- PreDoPTI
- Status last verified
- Sep 2025
- First submitted
- 24 Mar 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness and Comfort of Innovative Solutions for the Internal Transport of Patients in Wheelchairs in a Hospital Setting
- ClinicalTrials.gov ID
- NCT06902883
- Acronym / sponsor ID
- PreDoPTI / 2024-A00077-40/1
- Conditions
- Hospitalized Patient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 30 Mar 2025 (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.
In 2006, 2012, and 2018, under the auspices of the Pain Control Committee, Gustave Roussy stretcher-bearers conducted studies on patient pain caused by internal transport (stretchers). The first study showed that this pain is primarily experienced by patients initially in pain, and that risk factors include crossing elevator landings and threshold bars, handling, and prolonged waiting times.
A progress plan was developed, and since 2006, improvement initiatives have been regularly implemented. Their effectiveness has been evaluated by patients and the professionals involved (departure department, carrier, and arrival department).
Stretcher-bearing software was purchased following the original study; scheduling has been streamlined, journeys are transmitted to stretcher-bearers via smartphones, and transport times are calculated and analyzed. In 2019, a prototype for connecting patients' IV poles to wheelchairs was developed and tested, thanks to a collaboration between technical services, stretcher-bearers, and the Bureau of Biostatistics and Epidemiology. The time spent by stretcher-bearers transferring infusion sets and other syringe pumps from the patient's IV pole to the wheelchair's pole on the way out, and vice versa on the way back to the room, has been eliminated. The hypothesis is that this elimination would reduce travel times and could have an indirect impact on reducing pain.
Wheelchair comfort has been continually improved since 2006: the front casters were replaced with softer and thicker ones, the rear wheels with soft wheels and then with pneumatic tires; the backrests were replaced with a memory foam model, and the seats with an "ultra-comfort" model. These improvements contribute to better pain management during transport and an improved patient experience. Wheelchair comfort could be further improved by replacing the seats with high-quality "Bultex" models.
In 2022, 33,800 patients were transported in wheelchairs (round trip, one-way or one-way), representing 35% of annual transports. Technical developments and improvements in wheelchair comfort could contribute to reducing pain caused by internal transport.
Primary Objective To evaluate the effect of two interventions (a system for connecting the IV pole to the wheelchair and a new seat) during the internal transport of cancer patients being treated at Gustave Roussy:
Intervention 1: To evaluate the impact of using the IV pole connection system on reducing the duration of wheelchair transport for patients receiving infusions; Intervention 2: To evaluate patient preference for the comfort of a wheelchair seat.
Secondary Objective To evaluate pain in transported patients (before/after)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheelchair test 1 | Experimental | Device: Serum holder connected to the wheelchair, Device: wheelchair seatPatient will test experimental wheelchair during outward journey and standard wheelchair during return journey |
| Wheelchair test 2 | Experimental | Device: Serum holder connected to the wheelchair, Device: wheelchair seatPatient will test standard wheelchair during outward journey and experimental wheelchair during return journey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed patient and signed informed consent
- Age equal or greater than 18
- Speak and read french
- For serum holder connected to wheelchair only : patients with multiple infusion devices and transported in wheelchair
- For wheelchair seat : patients transported in wheelchair from hospitalized unit to radiology department
Key exclusion criteria (3 listed)
- disoriented or confused patient
- Patients under judicial protection (curatorship, tutorship) and/or deprived of freedom
- pregnant or breastfeeding women
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 |
|---|---|---|
| Serum holder connected to the wheelchairSerum holder connected to the wheelchair | Device | Wheelchair test 1, Wheelchair test 2 |
| wheelchair seatwheelchair seat | Device | Wheelchair test 1, Wheelchair test 2 |
Primary outcome
Period of transportation
Time frame: 1 day
Unit of measurement: minute
Comfort of the wheelchair
Time frame: 1 day
Comfort of the wheelchair evaluated according to satisfaction scale from 0 (uncomfortable) to 10 (very comfortable)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serum holder connected to the wheelchair and wheelchair seat in people with Hospitalized Patient, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 4 Sep 2025. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period of transportation (time frame: 1 day). The study lists 2 primary outcomes in all. 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 4 Sep 2025.