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

April 30, 2024 updated by: GIE Medical
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • Arkansas Gastroenterology
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Colorado Springs, Colorado, United States, 80907
    • Florida
    • Georgia
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Gastroenterology Associates of Central Georgia, LLC
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Kentucky
    • Louisiana
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • New York Presbyterian Hospital- Columbia University Medical Center
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Oregon
      • Portland, Oregon, United States, 97229
        • Recruiting
        • Oregon Health and Science University
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Contact:
          • Michael Anderson
        • Contact:
          • Phone Number: 4122288310
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Washington
      • Seattle, Washington, United States, 98122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Outcome
Time Frame: 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)
30 Days Post-Treatment
Treatment Success
Time Frame: 6 Months Post-Procedure
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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GIE Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR2052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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