NOW ENROLLING
If you’re suffering from recurrent esophageal stricture, there is hope with potential breakthrough technology designed to provide lasting relief.
This clinical study is being conducted across the United States to assess the safety and efficacy of a new investigational procedure combining standard balloon dilation to open the esophagus with drug delivery designed to maintain symptom relief. The ProTractX3 DCB is approved in the US for investigational use only.
Consider participating and you could:
-
Gain access to investigational treatment options.
-
Help advance medical knowledge for esophageal care.
Potential benefits include:
-
Relief from obstructive symptoms with the possibility of longer-lasting effects.
-
A straightforward outpatient procedure designed for convenience.
Click HERE to watch an animation of the ProTractX3™ endoscopic balloon dilation treatment. This video demonstrates how the balloon works during the procedure, giving you a clearer understanding of what to expect.
You may be eligible to participate in this study if:
Diagnosis
You have been diagnosed with difficulty swallowing (dysphagia) or an esophageal stricture, which is an abnormal narrowing of the esophagus.
Previous Treatment
You have undergone prior treatment for difficulty swallowing.
Current Symptoms
You are currently experiencing difficulty swallowing and are seeking treatment.
Participation
You are willing to receive study treatment and participate in follow-up appointments.
To be considered for this potentially breakthrough treatment, please use the contact number provided in the text, email or letter you received from your provider or contact clinicalstudy@giemedical.com.
Early Clinical Experience and Publications
The ProTractX3 DCB has been studied in two single-arm clinical studies evaluating safety and clinical outcomes in patients with recurrent esophageal strictures.
The INGEST Study
The INGEST study was a first-in-human feasibility study evaluating the safety and clinical outcomes after treatment with the ProTractX3 DCB.
-
Nine subjects with symptomatic recurrent esophageal strictures were enrolled and dilated with the ProTractX3 DCB.
-
Prior to treatment, on average subjects had difficulty swallowing more than soft foods and had undergone at least two prior treatments for their stricture.
-
Subjects have been followed for two years after treatment.
-
On average, subjects returned to being able to eat a normal diet after treatment.
-
One subject experienced recurrent symptoms and underwent additional dilation.
The PATENT-E Pharmacokinetic (PK) Sub-Study
The PATENT-E PK sub-study is a single-arm cohort evaluating paclitaxel concentration in plasma after treatment with the ProTractX3 DCB, as well as safety and clinical outcomes after treatment.
-
Twenty-four subjects with symptomatic, recurrent esophageal strictures were enrolled and dilated with the ProTractX3 DCB.
-
Prior to enrollment, subjects had undergone a median of 6 prior dilations with 8 of the 24 having more than 10 prior dilations.
-
All subjects had experienced stricture recurrence within a year of their last prior treatment.
-
Follow-up is ongoing for these subjects, with 23 having completed at least 6 months of follow-up.
-
Ten of the 23 remained free from stricture recurrence through follow-up, and the median time to recurrence increased from 100 days to 203 days.
Figure 1. Kaplan-Meier curve showing time to recurrence after the last dilation prior to entry (History) vs time to recurrence after treatment with the DCB. Data on file.
The randomized portion of the PATENT-E study is currently enrolling.
Commonly asked questions
How is the ProTractX3 different than standard dilation?
The design of the ProTractX3 is similar to standard balloon dilators commonly used to relieve dysphagia. A unique coating with the drug paclitaxel is applied to the outside of the balloon and delivered to the esophagus, with the intent of blocking the scar tissue that can occur after dilation, which might lead to the stricture coming back.
What is paclitaxel? How does it work?
Paclitaxel is a well-known drug that has been shown to prevent cell growth. The ability of paclitaxel to prevent recurrence of a narrowing in blood vessels and the urethra has been established. It is not yet known whether paclitaxel will work in a similar way for esophageal strictures.
Where else has Paclitaxcel been used?
Paclitaxel has been used in chemotherapy since the early 1990s. It has also been used in drug eluting stents for the treatment of blood vessels since 2004. More recently, paclitaxel coated balloons have been used to treat urethral strictures in men.
The dosage used in the ProTractX3 DCB coating is approximately one-hundred times less than the dose used in chemotherapy.
Who is funding this study?
The study is being funded by the manufacturer of the ProTractX3 DCB, GIE Medical.
Are participants being paid?
Participation in the study is voluntary. Participants will receive a travel stipend.
To be considered for this potentially breakthrough treatment, please use the contact number provided in the text, email or letter you received from your provider or contact clinicalstudy@giemedical.com.