Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
WITHDRAWN
NCT07558330
NA

Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2026-11-01

Completion Date

2027-11-01

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DEVICE

MAELA

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

Locations (5)

CH Sud Francilien

Corbeil-Essonnes, France

Hôpital Nord

Marseille, France

CHRU Nancy Brabois

Nancy, France

Hôpital Saint-Antoine

Paris, France

CHU Rouen

Rouen, France