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

GIE Medical

Status and phase: Enrolling; Phase 3

Conditions: Esophageal Stricture

Treatments: Other: Control; Combination Product: GIE Medical ProTractX3 TTS DCB

Study type: Interventional

Funder types: Industry

Identifiers

NCT05561114

PR2052

Details and patient eligibility

About

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

Enrollment: 198 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 22 years

2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations, at least one of which occurred in the last 12 months and achieved a diameter of 15mm

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 (e.g. 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

GIE Medical ProTractX3 TTS DCB

Experimental group

Description:

The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Treatment:

Combination Product: GIE Medical ProTractX3 TTS DCB

Control

Active Comparator group

Description:

Standard of Care Endoscopic Dilation

Treatment:

Other: Control