At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- MobiusHD™ (device)
- How long the study runs
- Study runs about 119 months (dates as stated)
- About the drug or intervention
- MobiusHD™ — device: The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 200
- Started
- 2016-07
- Last checked
- 2023-10
Plain English Summary
What is this study?
- • Testing a new treatment for hypertension
- • NA - 200 participants
- • To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with hypertension
Where?
- • Glasgow - Queen Elizabeth University Hospital - Glasgo
- • Glasgow - Golden Jubilee National Hospital
- • Brighton - The Royal Sussex County Hospital
- • London - St. Bartholomew's Hospital
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
More detail
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen...
Who cannot take part
- ✗Known or clinically suspected baroreflex failure or autonomic neuropathy
- ✗Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair...
- ✗Inclusion Criteria:
- ✗\- Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion...
- ✗Exclusion Criteria:
See the full criteria
Where Is This Study? (7 UK sites)
Queen Elizabeth University Hospital - Glasgo
Glasgow G51 4TF, United Kingdom
Golden Jubilee National Hospital
Glasgow G81 4DY, United Kingdom
The Royal Sussex County Hospital
Brighton BN2 5BE, United Kingdom
St. Bartholomew's Hospital
London EC1A 7BE, United Kingdom
St. Thomas' Hospital
London SE1 7EH, United Kingdom
University College London Hospital
London WC1E 6HX, United Kingdom
Manchester University
Manchester M13 9PL, United Kingdom
How to Get in Touch
Lisa Green
Sponsor contactCONTACT