New Clinical Trial currently enrolling patients at UNC-Chapel Hill:

Dear Doctor,

I am writing to inform you about an important new clinical trial currently enrolling patients at UNC-Chapel Hill. The PATENT-E Clinical Study is designed to evaluate the safety and efficacy of GIE Medical’s ProTractX3™ TTS DCB for the treatment of benign esophageal strictures. The ProTractX3 DCB combines standard balloon dilation to open the esophagus and drug delivery (Paclitaxel) designed to maintain symptom relief. The procedure is similar to standard dilation, takes about an hour to complete, and is done on an outpatient basis.

The primary eligibility criteria for the PATENT-E study include the following:

  1. Age ≥ 22 years
  2. Diagnosis of a benign esophageal stricture with at least two previous dilations
  3. Ogilvie Dysphagia Score of ≥2 (i.e., soft-food diet)
  4. Minimum esophageal lumen diameter <13 mm
  5. Willing and able to complete protocol required follow-up visits
  6. Willing and able to provide written informed consent
  7. Strictures ≤5cm in total length
  8. Target benign esophageal stricture etiologies include:
    • Peptic stricture
    • Schatzki’s ring
    • Stricture due to prior infection
    • Post-procedural (e.g., ESD/EMR/RFA/Cryo) stricture
    • Post-surgical (e.g., anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy

We would very much like your help in enrolling patients in this important study. If you believe your patient would be a candidate for this study, please contact us at 919-843-3946.

If you are interested in more details about the device used in this clinical investigation, please visit the sponsor’s website at giemedical.com or https://clinicaltrials.gov/study/NCT05561114.

Posted by:

Nicholas J. Shaheen, MD, MPH
University of North Carolina School of Medicine