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Brachytherapy
CivaSheet for Pancreatic Cancer
Phase 1
Waitlist Available
Research Sponsored by CivaTech Oncology
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 1.5 years
Awards & highlights
Study Summary
This trial is testing a new cancer radiation device that may better target cancer while sparing healthy tissue.
Eligible Conditions
- Pancreatic Cancer
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Directional Brachytherapy Source ImplantExperimental Treatment1 Intervention
Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CivaSheet
2017
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
CivaTech OncologyLead Sponsor
6 Previous Clinical Trials
304 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of alcoholism or drug abuse.You have already received chemotherapy treatment in the past.You have a tumor that has come back or was removed before.You are scheduled to have surgery to remove pancreatic cancer.You have received radiation therapy in the past for a different type of cancer.You had any type of cancer, except for basal cell skin cancer, within the last 5 years.You are pregnant or currently breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Directional Brachytherapy Source Implant
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.
To what extent could CivaSheet affect the health of those administering it?
"CivaSheet's safety rating is 1 out of 3, as this trial remains in its early stages and limited research has been conducted to confirm efficacy or safety."
Answered by AI
Are there any opportunities for prospective participants to get involved in this research?
"As per clinicaltrials.gov, this medical experiment is not currently accepting applications despite having been initially advertised on September 6th 2017 and updated most recently on March 1st 2022. Fortunately, 1172 other trials are actively recruiting at the moment."
Answered by AI
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