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Tests treatment safety and results for Biliary Obstruction
Official title UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
ClinicalTrials.gov ID: NCT04929821
What this study is testing
- What it's testing
- STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY OBJECTIVES Clinical /Technical /Procedural success, Quality of Life improvement, biodegradation rate
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
- 1) A subject with a biliary stricture may be entered into the study with: at least one of the following:
- Benign fibrotic distal bile duct obstruction
- Duct occlusion caused by cholelithiasis
- A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance...
- Ductal anastomotic strictures
You likely can't join if
- Patients, male or female, presenting with the following criteria may be included:
- Subject is unwilling to comply with the follow-up schedule
- Life expectancy \< 12 m,
- Inability to pass a guidewire through stricture
- Contra-indication for endoscopy or treatment radiology
- History of allergic reactions to one of the compounds of investigational product.
See the full eligibility criteria
- 1) A subject with a biliary stricture may be entered into the study with: at least one of the following:
- Benign fibrotic distal bile duct obstruction
- Duct occlusion caused by cholelithiasis
- A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance cholangiopancreatography (MRCP) and/or ERCP with proximal ductal dilation and cholestatic...
- Ductal anastomotic strictures
- Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla.
- Neoplasm diagnosed on clinical and imaging findings
- Post-ERCP pancreatitis
- Obstructive jaundice with evidence of pruritus, tea color urine and pale stool
- Abnormal Bilirubin rate or
- A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or
- A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old
- Patients, male or female, presenting with the following criteria may be included:
- Subject is unwilling to comply with the follow-up schedule
- Life expectancy \< 12 m,
- Inability to pass a guidewire through stricture
- Contra-indication for endoscopy or treatment radiology
- History of allergic reactions to one of the compounds of investigational product.
- Subject is unable or refuses to give informed consent
- Subject is pregnant or breastfeeding
- Patient under tutorship
- Currently participating in another trial before reaching first endpoint.
- Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma
- Patient need additional biliary stenting with another device than the study device. \-
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
- Hyderabad, India
- Kuala Lumpur, Malaysia
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 Hong Kong, Hong Kong; Hyderabad, India; Kuala Lumpur, Malaysia. 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.