Paclitaxel Coated Balloon for the Treatment of Chronic Benign Stricture- Esophagus

What is the Purpose of this Study?

The purpose of this study is to assess the safety and effectiveness of an experimental device called the ProTractX3 TTS drug-coated balloon (DCB) for the treatment of benign (non-cancerous) stricture in the esophagus. A stricture is a narrowing and/or scarring of a passageway in the body which can occur in the esophagus, making it difficult to swallow food. It is common practice for doctors to use balloons or other devices to stretch and expand a stricture. The ProTractX3 DCB coating contains paclitaxel, an anti-inflammatory and anti-proliferative (anti-overgrowth) drug commonly used in the treatment of cancer. Researchers want to determine whether this drug-coated balloon dilation device can treat strictures and reduce the rate of recurrence. Participants will be randomly assigned to receive treatment with either the ProTractX3 DCB (study device) or a normal dilation. (Participants are 2 times as likely to be treated by the study device compared to the standard-of-care treatment.)

Eligibility

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

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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Paclitaxel Coated balloon for the Treatment of chronic bEnigN sTricture- Esophagus

Study Details

Disease Type/Condition

Other

Principal Investigator

Lo, Simon

Age Group

Adult

Phase

N/A

IRB Number

STUDY00004018

ClinicalTrials.gov ID

NCT05561114

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org