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

Exclusion Criteria26

• Two or more clinically significant (e.g. non-traversable) strictures with total length >5cm or unable to be treated with a single balloon.
• Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months
• Contraindication to endoscopy, anesthesia or deep sedation
• Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment.
• History of diagnosis of eosinophilic esophagitis (EoE)
• 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.
• 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.
• Suspected perforation of gastrointestinal tract
• Inability to pass guidewire across stricture
• Active systemic infection
• Allergy to paclitaxel or structurally related compounds
• Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
• Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
• Received steroid injections into target stricture in the last 8 weeks.
• Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator
• Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function.
• Acute stricture condition that requires emergent procedure (e.g. immediate dilation)
• Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc
• Life expectancy of less than 24 months
• 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
• Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint.
• Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc.
• Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy.
• Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility.
• Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists)
• Concurrent gastric and/or duodenal obstruction