NOW ENROLLING
If you’re suffering from recurrent bowel 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 bowel 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:
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Gain access to investigational treatment options.
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Help advance medical knowledge for bowel care.
Potential benefits include:
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Relief from obstructive symptoms with the possibility of longer-lasting effects.
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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 a bowel stricture (abnormal narrowing or tightening in the intestines that makes it difficult for food to pass and may lead to nausea, vomiting, and severe cramping).
Previous Treatment
You have undergone prior treatment for your bowel stricture such as balloon dilation or surgery.
Current Symptoms
You are currently experiencing symptoms related to bowel stricture disease and seeking treatment for them.
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 bowel strictures.
The POISE Study
The POISE study was a first-in-human study evaluating the safety and clinical outcomes after treatment of benign bowel strictures with the ProTractX3 DCB.
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Ten subjects with recurrent bowel strictures were enrolled and dilated with the ProTractX3 DCB.
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Prior to treatment, subjects were experiencing symptoms such as constipation, abdominal distention and vomiting. All subjects has at least two prior treatments for their bowel stricture.
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After treatment with the ProTractX3 DCB, the subjects' symptoms were generally mild and infrequent.
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All subjects' strictures were able to be passed with the endoscope at six months post-treatment, which is a measure of a successful treatment. No subjects required additional treatment for their bowel stricture through two years of follow up.
The PATENT-B Pharmacokinetic (PK) Sub-Study
The PATENT-B 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.
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Twenty-five subjects with symptomatic, recurrent bowel strictures were enrolled and dilated with the ProTractX3 DCB.
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Prior to enrollment, subjects had undergone an average of four dilations for their bowel stricture, with a median time to recurrence of 124 days.
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Follow-up is ongoing for these subjects, with 18 having completed the six-month primary endpoint assessment.
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Ten of the 18 subjects' strictures were able to be passed with the endoscope at the six month visit.
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-B 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 obstructive symptoms. A unique coating with the drug paclitaxel is applied to the outside of the balloon and delivered to the bowel, 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 bowel 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.