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

Esophageal Stricture Clinical Trial

— PATENT-E  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561114
• Other study ID #: PR2052
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2023
• Est. completion date: December 1, 2029

Study information

• Verified date: April 2024
• Source: GIE Medical
• Contact: Erika Wang
• Phone: 7633605659
• Email: wange[@]giemedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 1, 2029
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Stenosis
• Esophageal Stricture

Intervention

Combination Product:
• GIE Medical ProTractX3 TTS DCB
Paclitaxel Coated Balloon

Other:
• Control
Standard Endoscopic Dilation

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado
United States	Birmingham Gastroenterology Associates	Birmingham	Alabama
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	Rush University	Chicago	Illinois
United States	Peak Gastroenterology	Colorado Springs	Colorado
United States	University of Florida	Gainesville	Florida
United States	Borland-Groover	Jacksonville	Florida
United States	University of Louisville	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York Presbyterian Hospital- Columbia University Medical Center	New York	New York
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Orlando Health	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	The University of Utah	Salt Lake City	Utah
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GIE Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success	Freedom from 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	6 Months Post-Procedure
Primary	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	Freedom from symptom recurrence		6 Months Post-Procedure
Secondary	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
Secondary	Ogilvie Dysphagia Score =1 without clinically driven repeat intervention		6 Months Post-Procedure
Secondary	Improvement in Ogilvie Dysphagia Score		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary	Improvement in Dysphagia Handicap Index score		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary	Minimum esophageal stricture diameter		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary	Number of esophageal dilation procedures		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary	Freedom from clinical driven reintervention		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary	Freedom from symptom recurrence		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary	VAS for pain scores		30 Day Follow-up
Secondary	Composite EQ-5D quality of life scores		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary	Dilations per year before and after treatment		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.
Secondary	Time between dilations		30 Days, 3 Months, 6 Months, 12 months, and annually thereafter through 5 years.