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
- Perivascular dexamethasone (combination product), Perivascular sham (combination product)
- How long the study runs
- Study runs about 88 months (dates as stated)
- About the drug or intervention
- Perivascular dexamethasone — combination product: Dexamethasone delivery around target vein segment(s) · Perivascular sham — combination product: Saline delivery around target vein segment(s)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 89 Years
- Who
- All
- Number of participants
- 80
- Started
- 2021-10-29
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for thrombosis, deep vein
- • Phase2 - 80 participants
- • This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization
Who can take part?
- • Ages 18 Years to 89 Years
- • Diagnosed with thrombosis, deep vein
Where?
- • London - Guy's and St. Thomas Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.
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 - 89 Years
- Who can join: All genders
What the study is looking for
- ✓Provision of signed and dated agreement to take part form prior to receiving any non-the usual treatment, protocol-specific...
- ✓Stated willingness to comply with all study procedures including completion of questionnaires and follow-up visits...
- ✓Male or female, aged 18 to 89 years.
- ✓Onset of acute DVT symptoms of 14 days or less prior to initial intervention in the study limb.
- ✓Ability to take oral medication and be willing to adhere to the prescribed anti-coagulant regimen.
Who cannot take part
- ✗Lack of capability of understanding the nature, significance and implications of the clinical trial.
- ✗Body Mass Index between 40 kg/m2 and 45 kg/m2, with significant other health condition which, in the Investigator's discretion,...
- ✗Body Mass Index \> 45 kg/m2.
- ✗Non-ambulatory status prior to DVT occurrence.
- ✗In the contralateral (non-study) leg: causing symptoms DVT that, in the opinion of the operating physician, will require...
See the full criteria
Where Is This Study? (1 UK site)
Guy's and St. Thomas Hospital
London SE1 7EH, United Kingdom
How to Get in Touch
Kirk Seward, PhD
Sponsor contactCONTACT
