BridgeMD
New treatment option for Pancreatic Necrosis
Official title Necrosectomy With Cryotechnology for Accelerated Removal
ClinicalTrials.gov ID: NCT06553651
What this study is testing
- What it's testing
- Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death.
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
- people aged 18 years and above, inclusive of both males and females.
- Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic...
- Imaging indicative of ≥30% necrotic material within the pancreas.
- Walled-off pancreatic necrosis (WOPN) size ≥6 cm.
- people able to tolerate repeated endoscopic procedures.
You likely can't join if
- Inability to provide informed consent.
- Unwillingness to undergo repeated endoscopies.
- Presence of documented Pseudoaneurysm \> 1cm within the WOPN.
- Intervening gastric varices or unavoidable blood vessels within the access tract.
- Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.
- Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
See the full eligibility criteria
- people aged 18 years and above, inclusive of both males and females.
- Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage.
- Imaging indicative of ≥30% necrotic material within the pancreas.
- Walled-off pancreatic necrosis (WOPN) size ≥6 cm.
- people able to tolerate repeated endoscopic procedures.
- Capacity for providing informed consent.
- Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+/- 7) days.
- Inability to provide informed consent.
- Unwillingness to undergo repeated endoscopies.
- Presence of documented Pseudoaneurysm \> 1cm within the WOPN.
- Intervening gastric varices or unavoidable blood vessels within the access tract.
- Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.
- Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
- Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
- Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Boston, Massachusetts, 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.