Digestive CancersCODAPNCT07558330
Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery
A study testing MAELA in people with Digestive Cancers, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial summary
In France, digestive cancers are responsible for more than 40,000 deaths per year, or approximately 30% of cancer-related deaths. Surgery is central to the patient's journey, particularly their treatment, and postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or related to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Cancers
- What is being tested?
- MAELA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Interventional
- 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
- Patient aged 18 years and older
- Patient scheduled for digestive oncology surgery:
- Colectomy for cancer
- Pancreatectomy for cancer
- Hepatectomy for cancer
- Proctectomy for cancer
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- Gastrectomy for cancer
- Esophagectomy for cancer
- At least 2 weeks between scheduling and surgery
- Patient with a smartphone (iOS or Android environment), or living with family members/primary caregivers who have a smartphone with access to cellular data/Wi-Fi
- Subject affiliated with or beneficiary of a health insurance plan
- Subject who can read and understand French
- Subject who has signed informed consent
Who cannot join
- Patient already participating in an interventional clinical trial
- Adult patient subject to a legal protection measure, guardianship, or deprived of liberty by a judicial or administrative decision
- Patient unable to complete a questionnaire and without a close caregiver to support the use of the solution
- Patient with a psychiatric disorder that would prevent them from giving informed consent or receiving optimal treatment and follow-up
- Minor patient
- Visually impaired patient
Show all 11Show fewer
- Patient with significant psychomotor disorders of the upper limbs
- Patient with memory disorders
- Patient without a mobile phone number
- Patient without internet access
- Pregnant or breastfeeding woman
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH Sud Francilien
Corbeil-Essonnes, 91100
Hôpital Nord
Marseille, 13015
CHRU Nancy Brabois
Nancy, 54500
Hôpital Saint-Antoine
Paris, 75012
CHU Rouen
Rouen, 76000
About this study
In France, digestive cancers are responsible for more than 40,000 deaths per year, or approximately 30% of cancer-related deaths.
Surgery is central to the patient's journey, particularly their treatment, and postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or related to postoperative pain, remain common and can have a significant impact on patients' quality of life and long-term outcomes.
Read more
The implementation of continuous monitoring contributes to optimizing the care pathway and is necessary to improve postoperative outcomes.
Postoperatively, remote monitoring has proven its effectiveness in significantly reducing postoperative readmission rates, particularly among patients who have undergone colorectal surgery.
It allows for rapid intervention in the event of frequent complications, thus preventing unnecessary hospitalizations.
To date, no study has evaluated the efficacy and safety of such a remote monitoring tool compared to conventional management on the clinical and organizational consequences postoperatively.
Maela® is an app that allows patients to complete a symptom tracking questionnaire using a mobile device for 90 days following surgery. Surgeons can track new alerts via the solution's web interface.
The primary objective of the study is to evaluate the clinical efficacy of the Maela® medical remote monitoring device after elective digestive oncology surgery compared to conventional management.
- Conditions
- Digestive Cancers
- Being tested
- MAELA
- Keywords
- digestive cancer, Surgery, post-operative complication, remote monitoring
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAELADevice
Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery.
Maela will be use by patient to answer online questionnaire, which will generate alerts based on the responses.
If an alert is generated, the surgeon or their nurse may see the patient early and adapt the care. The management will be at the discretion of the healthcare professionals
| Study group | Role | What they receive |
|---|---|---|
| MAELA | Experimental | Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery Receives: Device: MAELA |
| Standard of care | No intervention | Control group without remote monitoring and following standard monitoring according to the conventional care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
Presence/absence at day 90 post-surgery defined as the composite of :
- A grade III to IV complication according to the Clavien-Dindo classification AND/OR
- A post-operative readmission related to surgery (defined by an unscheduled readmission and/or a visit to the emergency room).
Measured: Day 90 post-surgery
Secondary outcomes (15)
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Presence of at least one grade III to IV complication according to the Clavien-Dindo scale at Day 30 and day 90 post-surgery
Measured: Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Number of postoperative readmissions related to surgery (defined by an unscheduled readmission and/or a visit to the emergency room) at Day 30 and day 90 post-surgery
Measured: Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Number of postoperative complications according to grade according to the Clavien-Dindo classification at Day 30 and day 90 post-surgery
Measured: Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Number of prolonged hospital stays defined as the 75th percentile of the initial length of stay in hospitalized patients at Day 30 and day 90 post-surgery
Measured: Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Change in pain intensity on Day 1 (24 hours post-surgery) assessed by the VAS scale (0-10) at Day 30 and day 90 post-surgery
Measured: Day 1 (24 hours), Day 30 and day 90 post-surgery
Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life
Change in quality-of-life score using the EORTC QLQ C30 questionnaire at inclusion, D30 and D90
Measured: D0, Day 30 and day 90 post-surgery
Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life
Change in postoperative recovery quality score using the QoR-15 scale (0-10) at D1 (24 hours post-surgery), D30 and D90
Measured: D1 (24hours), Day 30 and Day 90 post-surgery
Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping
Number of days spent outside the hospital (initial hospitalization and re-hospitalization) within 90 days following surgery
Measured: Day 90 post-surgery
Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping
Number of unscheduled consultations without hospitalization and related to surgery (with a general practitioner or surgeon) within 90 days following surgery
Measured: Day 90 post-surgery
Evaluate the medical and economic benefit of patient monitoring with the Maela® solution
Evaluate the medical and economic benefit of patient monitoring with the Maela® solution
Measured: Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Monthly compliance rate for remote monitoring at D30 and D90, defined by the formula: Compliance rate = (Number of completed questionnaires / Total number of questionnaires) x 100
Measured: Day 30 and day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Average alert management time, defined by the time between alert issuance and resolution at D90
Measured: Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Usability assessed by the French version of the SUS (System Usability Scale) questionnaire by patients at D90
Measured: Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Patient satisfaction assessed by a specific qualitative questionnaire completed at D90
Measured: Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Healthcare professional satisfaction assessed by a specific qualitative questionnaire completed at the end of each period (control and intervention)
Measured: At the end of the control period (Month 1 to Month 6, depending of the time the intervention begin) and at the end of the interventionnal period (Month 12) for each center
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Why it stopped: Inability to complete the study within the alloted time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CancersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a multicenter, national, prospective, open-label, controlled, and randomized clinical superiority study conducted at the Stepped Wedge Cluster Randomized Trial (SWT): * Control period: conventional care pathway in accordance with each center's usual management. * Intervention period: care pathway managed by the Maela® solution. Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Lariboisière Fernand Widal, Hotel Dieu Hospital, MN Santé
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558330
- Sponsor's protocol ID
- APHP241518
- Acronym
- CODAP
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery
- ClinicalTrials.gov ID
- NCT07558330
- Acronym / sponsor ID
- CODAP / APHP241518
- Conditions
- Digestive Cancers
- Keywords
- digestive cancer, Surgery, post-operative complication, remote monitoring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to complete the study within the alloted time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hôpital Lariboisière Fernand Widal, Hotel Dieu Hospital, MN Santé
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 30 Apr 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.
In France, digestive cancers are responsible for more than 40,000 deaths per year, or approximately 30% of cancer-related deaths.
Surgery is central to the patient's journey, particularly their treatment, and postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or related to postoperative pain, remain common and can have a significant impact on patients' quality of life and long-term outcomes.
The implementation of continuous monitoring contributes to optimizing the care pathway and is necessary to improve postoperative outcomes.
Postoperatively, remote monitoring has proven its effectiveness in significantly reducing postoperative readmission rates, particularly among patients who have undergone colorectal surgery.
It allows for rapid intervention in the event of frequent complications, thus preventing unnecessary hospitalizations.
To date, no study has evaluated the efficacy and safety of such a remote monitoring tool compared to conventional management on the clinical and organizational consequences postoperatively.
Maela® is an app that allows patients to complete a symptom tracking questionnaire using a mobile device for 90 days following surgery. Surgeons can track new alerts via the solution's web interface.
The primary objective of the study is to evaluate the clinical efficacy of the Maela® medical remote monitoring device after elective digestive oncology surgery compared to conventional management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, national, prospective, open-label, controlled, and randomized clinical superiority study conducted at the Stepped Wedge Cluster Randomized Trial (SWT): * Control period: conventional care pathway in accordance with each center's usual management. * Intervention period: care pathway managed by the Maela® solution. Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery.
| Arm | Type | Receives |
|---|---|---|
| MAELA | Experimental | Device: MAELAPatients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery |
| Standard of care | No intervention | –Control group without remote monitoring and following standard monitoring according to the conventional care pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient aged 18 years and older
- Patient scheduled for digestive oncology surgery:
- At least 2 weeks between scheduling and surgery
- Patient with a smartphone (iOS or Android environment), or living with family members/primary caregivers who have a smartphone with access to cellular data/Wi-Fi
- Subject affiliated with or beneficiary of a health insurance plan
Key exclusion criteria (11 listed)
- Patient already participating in an interventional clinical trial
- Adult patient subject to a legal protection measure, guardianship, or deprived of liberty by a judicial or administrative decision
- Patient unable to complete a questionnaire and without a close caregiver to support the use of the solution
- Patient with a psychiatric disorder that would prevent them from giving informed consent or receiving optimal treatment and follow-up
- Minor patient
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 |
|---|---|---|
| MAELAPatients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery. Maela will be use by patient to answer online questionnaire, which will generate alerts based on the responses. If an alert is generated, the surgeon or their nurse may see the patient early and adapt the care. The management will be at the discretion of the healthcare professionals | Device | MAELA |
Primary outcome
Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
Time frame: Day 90 post-surgery
Presence/absence at day 90 post-surgery defined as the composite of : * A grade III to IV complication according to the Clavien-Dindo classification AND/OR * A post-operative readmission related to surgery (defined by an unscheduled readmission and/or a visit to the emergency room).
15 secondary outcomes
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Time frame: Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Time frame: Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Time frame: Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Time frame: Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Time frame: Day 1 (24 hours), Day 30 and day 90 post-surgery
Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life
Time frame: D0, Day 30 and day 90 post-surgery
Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life
Time frame: D1 (24hours), Day 30 and Day 90 post-surgery
Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping
Time frame: Day 90 post-surgery
Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping
Time frame: Day 90 post-surgery
Evaluate the medical and economic benefit of patient monitoring with the Maela® solution
Time frame: Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Time frame: Day 30 and day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Time frame: Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Time frame: Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Time frame: Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Time frame: At the end of the control period (Month 1 to Month 6, depending of the time the intervention begin) and at the end of the interventionnal period (Month 12) for each center
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAELA in people with Digestive Cancers, run by Assistance Publique - Hôpitaux de Paris at 5 sites 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 13 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: withdrawn, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management (time frame: Day 90 post-surgery). 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 6 Jul 2026.