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New treatment option for Bile Duct Adenocarcinoma
Official title Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
ClinicalTrials.gov ID: NCT07120295
What this study is testing
- What it's testing
- This study plans to enroll up to 75 research subject who have a biliary disorder such as bile duct stones or intermediate biliary strictures. The purpose of this research is to assess whether the Dragonfly™ Pancreaticobiliary Scope functioned as intended in combination with the commercially available accessories during your scheduled endoscopy procedure.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Provision to sign and date the consent form;
- Adult patients ≥ 21 years old;
- Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform...
- Indeterminate biliary stricture, or
- Failed biliary stone extraction with conventional techniques.
You likely can't join if
- Pregnancy or lactation;
- Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
- Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
- Coagulopathy (INR \> 1.8) or thrombocytopenia (Platelets \< 50,000) that is not correctable and felt to be a contraindication to proceeding with...
- Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
- Patients who are not candidates for anesthesia to permit ERCP.
See the full eligibility criteria
- Provision to sign and date the consent form;
- Adult patients ≥ 21 years old;
- Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:
- Indeterminate biliary stricture, or
- Failed biliary stone extraction with conventional techniques.
- Willing and able to follow study procedures and comply with study follow-up.
- Pregnancy or lactation;
- Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
- Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
- Coagulopathy (INR \> 1.8) or thrombocytopenia (Platelets \< 50,000) that is not correctable and felt to be a contraindication to proceeding with biopsy or lithotripsy per the treating endoscopist;
- Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
- Patients who are not candidates for anesthesia to permit ERCP.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. 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.