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Procedure
EUS-Guided RFA for Pancreatic Cysts (ERASE Trial)
N/A
Recruiting
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time point 1: immediately post-procedure (after eus-rfa) in endoscopy unit up to 24 hours after procedure; time point 2: at one calendar year after eus-rfa
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a procedure that uses heat to destroy abnormal growths in the pancreas. It targets patients who cannot have surgery due to high risks. The heat is delivered through a special tool inserted via an endoscope. Early results show that this method is safe and feasible for patients who cannot undergo surgery.
Who is the study for?
This trial is for adults over 18 with pancreatic cysts who are high-risk for surgery due to conditions like liver cirrhosis, obesity, heart/lung issues, or by choice. They must have a specific type of cyst at least 2cm large and not be candidates for surgical treatment. Women must test negative for pregnancy.
What is being tested?
The ERASE study tests the safety and effectiveness of using an FDA-cleared device (EUS-RFA probe) to perform radiofrequency ablation on pancreatic cysts in patients unsuitable for surgery. Participants will undergo this procedure and then be monitored regularly over three years.
What are the potential side effects?
Potential side effects may include discomfort at the site of ablation, risk of infection, possible damage to nearby organs or blood vessels if the cyst is close to these structures, pancreatitis, or allergic reactions related to sedation during endoscopic procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at two and three calendar years after eus-rfa
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at two and three calendar years after eus-rfa
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assess the efficacy of EUS-RFA post-procedure after one year
Secondary study objectives
Assess the long-term response to EUS-RFA for efficacy of significant and durable ablation response
Incidence of adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EUS-guided radiofrequency ablation of pancreatic cystic lesion(s)Experimental Treatment2 Interventions
Single arm study. EUS-guided intervention with radiofrequency ablation of pancreatic cystic lesions. Primary population of interest: Branch duct IPMN (intraductal papillary mucinous neoplasm) with high-risk for surgical intervention. The intervention is performed using an FDA-cleared device (EUS-RFA probe).
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,129 Total Patients Enrolled
1 Trials studying Pancreatic Cyst
500 Patients Enrolled for Pancreatic Cyst
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to care for myself and spend most of my time in bed or a chair.My pancreatic cyst is at least 2 cm and has high-risk features.I am older than 18 years.My pancreatic cyst has been confirmed as cancerous with signs of spreading.I have not had acute pancreatitis in the last 4 weeks.I don't have severe illnesses that would make joining the study unsafe for me.My pancreatic cyst involves the main duct.My cysts or neuroendocrine tumors are near major blood vessels or bile ducts, risking damage if treated.I cannot have surgery and have tried chemotherapy injections for my pancreatic cyst.I have a condition like severe liver disease, obesity, heart/lung problems, or other serious health issues that make surgery too risky.My pancreatic cyst is benign, confirmed by specific tests.I am a woman who can have children and my pregnancy test today was negative.My pancreatic cyst was confirmed with specific advanced tests.I have been advised against surgery for my condition by specialists.I cannot have general anesthesia as determined by a pre-op assessment.I chose not to have surgery for my liver or pancreas condition after talking to a specialist.
Research Study Groups:
This trial has the following groups:- Group 1: EUS-guided radiofrequency ablation of pancreatic cystic lesion(s)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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