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Paclitaxel Coated Balloon for Esophageal Strictures (PATENT-E Trial)
Phase 3
Recruiting
Research Sponsored by GIE Medical
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 6 months post-procedure
Awards & highlights
PATENT-E Trial Summary
This trial is testing a new device to treat esophageal strictures, to see if it is safe and effective.
Who is the study for?
Adults over 22 with benign esophageal strictures, who've had at least two previous dilations in the last year. They must have a stricture less than 5cm long and be able to follow up. Pregnant women, those with certain medical conditions or allergies to paclitaxel, and patients on chronic steroids (unless they stop) can't join.Check my eligibility
What is being tested?
The trial is testing the ProTractX3™ Drug-Coated Balloon (DCB) against a control treatment for safety and effectiveness in treating non-cancerous narrowings of the esophagus that make swallowing difficult.See study design
What are the potential side effects?
Potential side effects may include reactions related to the device like pain or discomfort during treatment, as well as possible allergic reactions to paclitaxel used in the coating of the balloon.
PATENT-E Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Safety Outcome
Treatment Success
Secondary outcome measures
Composite EQ-5D quality of life scores
Dilations per year before and after treatment
Freedom from clinical driven reintervention
+9 morePATENT-E Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GIE Medical ProTractX3 TTS DCBExperimental Treatment1 Intervention
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Group II: ControlActive Control1 Intervention
Standard of Care Endoscopic Dilation
Find a Location
Who is running the clinical trial?
GIE MedicalLead Sponsor
4 Previous Clinical Trials
198 Total Patients Enrolled
1 Trials studying Esophageal Strictures
9 Patients Enrolled for Esophageal Strictures
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with eosinophilic esophagitis.I have a blockage in my stomach or upper small intestine.I am not pregnant, breastfeeding, nor planning to become pregnant in the next year.I cannot undergo endoscopy or be put under deep sedation due to health risks.I might have a tear in my digestive tract.A guidewire cannot be passed through my narrowed body passage.I am currently fighting an infection in my body.My esophageal stricture is due to a benign cause like acid reflux or a past procedure.I am allergic to paclitaxel or similar drugs.I don't have cancer in my esophagus or any signs of it coming back.I have a non-cancerous narrowing of my esophagus due to external pressure, chemical injury, or radiation treatment.I need an urgent procedure for a severe narrowing in my body.My condition involves severe complications like abscesses or fistulas.I have severe acid reflux damage to my esophagus.I am 22 years old or older.My esophagus is abnormally widened and may affect its movement.I have swallowing difficulties due to a disorder affecting my esophagus.I have received steroid injections into my narrowed area within the last 8 weeks.I am willing to stop taking steroids for 4 weeks if I use them for another condition.My cancer is metastatic, not in remission, or may need radiation in the throat/chest area.I have had my esophagus stretched twice in the last year due to a non-cancerous narrowing.I have a severe bleeding disorder or I'm on blood thinners that can't be safely adjusted.I have two or more significant blockages in my intestines that are longer than 5cm.I do not have any severe health issues that could affect my safety in the trial.
Research Study Groups:
This trial has the following groups:- Group 1: GIE Medical ProTractX3 TTS DCB
- Group 2: Control
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 total number of people taking part in this experiment?
"Yes, this is an ongoing study that was posted on October 1st, 2020 with a most recent update happening on September 27th, 2020. The trial is looking for 198 individuals at a single site."
Answered by AI
Has the FDA given its okay to GIE Medical ProTractX3 TTS DCB?
"GIE Medical ProTractX3 TTS DCB is a Phase 3 trial, which means that while there is some data supporting efficacy, multiple rounds of data have been collected to support safety. Consequently, our team at Power has given it a score of 3 for safety."
Answered by AI
Are people currently being signed up for this experiment?
"That is correct, the trial information available on clinicaltrials.gov states that this study is currently looking for participants. The posting date was October 1st, 2022 and the most recent edit was September 27th, 2022. They are seeking a total of 198 individuals at 1 locations."
Answered by AI
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