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

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

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

Conditions
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Esophageal Stricture

Intervention / Treatment
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* Combination Product: GIE Medical ProTractX3 TTS DCB
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 22 years Diagnosis of a benign esophageal stricture with at least 2 previous dilations to at least 14mm within the last 12 months Ogilvie Dysphagia Score of ≥2 Minimum esophageal lumen diameter <13 mm Willing and able to complete protocol required follow-up visits Willing and able to provide written informed consent Strictures ≤5cm in total length 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. Exclusion Criteria: 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, and purely radiation induced strictures (e.g. 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 throat 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 of 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 in the opinion of the investigator 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, hiatal hernia, 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 proton pump inhibitors Concurrent gastric and/or duodenal obstruction

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIE Medical ProTractX3 TTS DCB<br>The ProTractX3 Drug-coated balloon is a 0.035 guidewire compatible over-the-wire catheter. | Combination Product: GIE Medical ProTractX3 TTS DCB<br>* Paclitaxel Coated Balloon<br>|
| Active Comparator: Control<br>Standard of Care Endoscopic Dilation | Other: Control<br>* Standard Endoscopic Dilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success | Ogilvie Dysphagia Score ≤1 without clinically driven repeat intervention | 6 Months Post-Treatment | 
| Primary Safety Outcome | Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion) | 30 Days Post-Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from symptom recurrence | Symptom recurrence is defined as an Ogilvie Dysphagia Score of ≥2 or clinically driven reintervention. | 6 Months Post-Procedure | 
| Freedom from clinically driven reintervention | The rate of subjects free from clinically driven repeat intervention for the stricture treated at the index procedure in each arm will be assessed via Kaplan-Meier survival analysis. | 6 Months Post-Procedure | 
| Esophageal diameter ≥ 13mm | The proportion of subjects that successfully maintain an esophageal diameter ≥13mm through the 6 month visit, as measured by endoscopy. | 6 Months Post-Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal stricture, drug coated balloon, DCB, paclitaxel coated balloon