Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus (PATENT-E)

  • STATUS
    Recruiting
  • End date
    Feb 1, 2029
  • participants needed
    198
  • sponsor
    GIE Medical
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Updated on 12 September 2023
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Summary

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

Details
Condition Esophageal Stricture
Treatment Control, GIE Medical ProTractX3 TTS DCB
Clinical Study IdentifierNCT05561114
SponsorGIE Medical
Last Modified on12 September 2023

Eligibility

 Yes No Not Sure

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
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