BridgeMD
Compares treatment options for Reduction in the Initial Length of Stay
Official title An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.
ClinicalTrials.gov ID: NCT07552805
What this study is testing
- What it's testing
- The SENSE-ECO study is a prospective, randomized trial of 490 high-risk patients designed to show that the MultiSense® remote monitoring patch safely reduces hospital stays following major digestive surgery. By continuously tracking vital signs for five days at home, the device aims to maintain clinical safety and quality of life while decreasing overall healthcare costs for the French medical system.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults (aged 18 and over)
- Patients scheduled for gastrointestinal surgery :
- Major gastrointestinal cancer surgery (pancreas, liver, stomach, oesophagus, rectum)
- Colorectal surgery (rectal resection, surgery on the rectum and anus other than rectal resection, minor or major surgery on the small intestine and...
- Patients in non-critical care with a high risk of post-surgical complications (ASA score 2 or 3)
You likely can't join if
- Patients with a contraindication to the use of the device as described in the instructions for use (in particular: known skin allergy to adhesives or...
- Any other condition which, in the investigator's opinion, would compromise the patient's safety or prevent compliance with the requirements of the...
- Pregnant or breastfeeding patient
- Adult under legal protection (under guardianship, curatorship or judicial protection)
- Patient already participating in a clinical trial
See the full eligibility criteria
- Adults (aged 18 and over)
- Patients scheduled for gastrointestinal surgery :
- Major gastrointestinal cancer surgery (pancreas, liver, stomach, oesophagus, rectum)
- Colorectal surgery (rectal resection, surgery on the rectum and anus other than rectal resection, minor or major surgery on the small intestine and colon)
- Patients in non-critical care with a high risk of post-surgical complications (ASA score 2 or 3)
- Patients who have a personal mobile phone and Wi-Fi connectivity at home
- Patients who provide written informed consent to participate in the study
- Patients who are members of or beneficiaries of a social security scheme
- Patients who are proficient in French
- Patients with a contraindication to the use of the device as described in the instructions for use (in particular: known skin allergy to adhesives or silicone, active implantable medical device such as a pacemaker or...
- Any other condition which, in the investigator's opinion, would compromise the patient's safety or prevent compliance with the requirements of the protocol
- Pregnant or breastfeeding patient
- Adult under legal protection (under guardianship, curatorship or judicial protection)
- Patient already participating in a clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Nice, Alpes-Maritimes, France
- Besançon, Doubs, France
- Rouen, Seine-Maritime, France
- Amiens, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nice, Alpes-Maritimes, France; Besançon, Doubs, France; Rouen, Seine-Maritime, France; Amiens, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.