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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
ERASE Trial Summary
This trial will assess the safety & effectiveness of a minimally invasive procedure to treat pancreatic cystic lesions in patients who can't have surgery. Patients will be monitored for 3 yrs after treatment.
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.Check my eligibility
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.See study design
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.
ERASE Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the efficacy of EUS-RFA post-procedure after one year
Secondary outcome measures
Assess the long-term response to EUS-RFA for efficacy of significant and durable ablation response
Incidence of adverse events
ERASE 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
830 Previous Clinical Trials
505,592 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current capacity for participants in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical experiment began recruiting on April 24th 2023 and is still actively doing so as of June 14th 2022. Of the 28 participants needed for enrolment, only 1 site has been allocated thus far."
Answered by AI
Are there any open positions for this clinical trial at present?
"As per the records on clinicaltrials.gov, this research project is at present seeking participants. The trial was initially shared to public domain on April 24th 2023 and most recently updated on June 14th 2023."
Answered by AI
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