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Treatment of benign esophageal strictures using a paclitaxel coated balloon

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

Phase 3 Interventional GIE Medical · NCT05561114

This study is testing a new drug-coated balloon treatment to see if it can help people with benign esophageal strictures feel better after they've already had two other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment198 (estimated)
Ages22 Years and up
SexAll
SponsorGIE Medical Industry-sponsored
Drugs / interventionsradiation
Locations34 sites (Birmingham, Alabama and 33 other locations)
Trial IDNCT05561114 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the ProTractX3™ drug-coated balloon (DCB) for treating benign esophageal strictures. Participants will receive the DCB intervention after having undergone at least two previous dilations for their condition. The study aims to determine if this innovative approach can improve esophageal lumen diameter and alleviate symptoms associated with strictures. The trial will involve follow-up visits to monitor patient outcomes and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with a diagnosis of benign esophageal stricture who have had at least two prior dilations.

Not a fit: Patients with multiple significant strictures or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from benign esophageal strictures.

How similar studies have performed: Other studies have shown promise with drug-coated balloons in treating strictures, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 22 years
2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations
3. Ogilvie Dysphagia Score of ≥2
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:

   1. Peptic stricture,
   2. Schatzki's ring,
   3. Stricture due to prior infection,
   4. Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture
   5. Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy

Exclusion Criteria:

1. Two or more clinically significant (e.g. non-traversable) strictures with total length \>5cm or unable to be treated with a single balloon.
2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months
3. Contraindication to endoscopy, anesthesia or deep sedation
4. Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment.
5. History of diagnosis of eosinophilic esophagitis (EoE)
6. Signs or suspicion of a malignant esophageal stricture NOTE: If stricture is suspicious for malignancy based on clinical or endoscopic presentation, malignancy must be excluded by biopsy prior to enrollment. Subjects with a history of invasive esophageal cancer should have recurrence excluded by advanced imaging (e.g. CT/PET scan) and biopsy within 6 months of enrollment.
7. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the neck or thoracic region NOTE: A prior diagnosis of esophageal cancer is acceptable if considered in remission and recurrence has been excluded by advanced imaging and biopsy within 6 months of enrollment.
8. Suspected perforation of gastrointestinal tract
9. Inability to pass guidewire across stricture
10. Active systemic infection
11. Allergy to paclitaxel or structurally related compounds
12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
13. Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
14. Received steroid injections into target stricture in the last 8 weeks.
15. Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator
16. Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function.
17. Acute stricture condition that requires emergent procedure (e.g. immediate dilation)
18. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc
19. Life expectancy of less than 24 months
20. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, ongoing infection, etc
21. Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint.
22. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc.
23. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy.
24. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility.
25. Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists)
26. Concurrent gastric and/or duodenal obstruction

Where this trial is running

Birmingham, Alabama and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Esophageal Strictureesophageal stricturedrug coated balloonDCBpaclitaxel coated balloon
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.