Esophageal Stricture
Conditions
Keywords
esophageal stricture, drug coated balloon, DCB, paclitaxel coated balloon
Brief summary
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Interventions
COMBINATION_PRODUCTGIE Medical ProTractX3 TTS DCB
Paclitaxel Coated Balloon
OTHERControl
Standard Endoscopic Dilation
Sponsors
GIE Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | 6 Months Post-Procedure | 1\. The primary efficacy endpoint is freedom from stricture recurrence, measured as the time from Index procedure until stricture recurrence through 6 months post-procedure. Stricture recurrence is defined as an esophageal diameter \<13mm as measured using a functional luminal imaging probe, or clinically driven reintervention at the treated area within 6 months post-procedure as determined by the Clinical Events Committee |
| Primary Safety Outcome | 30 Days Post-Treatment | Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Responder Rate at 6 months | 6 Months Post-Procedure | — |
| Annualized Rate of Reintervention | Annually | The annualized reintervention rate is defined as the annualized number of clinically driven interventions and will be assessed by comparing the annualized rate per patient year between groups using a test of Poisson rates. |
| Freedom from symptom recurrence through 6 months post-procedure | 6 Months Post-Procedure | — |
| Freedom from clinically driven target stricture reintervention through 6 months post-procedure | 6 Months Post-Procedure | — |
| Diameter Improvement at 6 months | 6 Months Post-Procedure | The minimum esophageal stricture diameter will be assessed by a functional luminal imaging probe (EndoFLIP) during endoscopy and compared between the Test and Control arms. The minimum esophageal stricture diameter will be measured at baseline and during the 6-month follow-up, or at the time of a reintervention if one occurs prior to 6 months. |
Other
| Measure | Time frame |
|---|---|
| Number of esophageal dilation procedures through each follow up | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Freedom from clinically driven reintervention through each follow-up | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Secondary Patency | Time between the index procedure to the second clinically driven intervention |
| VAS for pain scores through 30-day follow-up | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Composite EQ-5D quality of life scores at each follow-up | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Freedom from symptom recurrence through each follow-up | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Technical Success | Procedure |
| Annualized rate of dilations before and after treatment | Annually |
| Improvement in time between dilations | Between Dilations |
| Improvement in Ogilvie Dysphagia Score at each follow-up | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Improvement in Dysphagia Handicap Index score at each follow-up | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Stricture characteristics per functional imaging | Between Dilations |
Countries
United States
Contacts
Primary ContactErika Wang
Outcome results
None listed