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

June 19, 2025 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
    • Arizona
    • California
      • Irvine, California, United States, 92697-7600
        • Recruiting
        • University of California, Irvine
        • Contact:
      • Lancaster, California, United States, 92534
      • Los Angeles, California, United States, 90048
      • San Diego, California, United States, 92103
        • Recruiting
        • San Diego Gastroenterology
        • Contact:
    • Colorado
    • Florida
    • Georgia
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Gastroenterology Associates Of Central Georgia, LLC
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Kansas
      • Wichita, Kansas, United States, 67226
    • Kentucky
    • Louisiana
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Missouri
      • St Louis, Missouri, United States, 63130
    • Nevada
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
    • 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
      • 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
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Washington
      • Seattle, Washington, United States, 98122
    • West Virginia
      • Morgantown, West Virginia, United States, 26501

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
  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

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
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
6 Months Post-Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Rate of Reintervention
Time Frame: 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.
Annually
Diameter Improvement at 6 months
Time Frame: 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.
6 Months Post-Procedure
Clinical Responder Rate at 6 months
Time Frame: 6 Months Post-Procedure
6 Months Post-Procedure
Freedom from clinically driven target stricture reintervention through 6 months post-procedure
Time Frame: 6 Months Post-Procedure
6 Months Post-Procedure
Freedom from symptom recurrence through 6 months post-procedure
Time Frame: 6 Months Post-Procedure
6 Months Post-Procedure

Other Outcome Measures

Outcome Measure
Time Frame
Technical Success
Time Frame: Procedure
Procedure
Secondary Patency
Time Frame: Time between the index procedure to the second clinically driven intervention
Time between the index procedure to the second clinically driven intervention
Annualized rate of dilations before and after treatment
Time Frame: Annually
Annually
Improvement in time between dilations
Time Frame: Between Dilations
Between Dilations
Improvement in Ogilvie Dysphagia Score at each follow-up
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 at each follow-up
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
Stricture characteristics per functional imaging
Time Frame: Between Dilations
Between Dilations
Number of esophageal dilation procedures through each follow up
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 clinically driven reintervention through each follow-up
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 through each follow-up
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 through 30-day follow-up
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
Composite EQ-5D quality of life scores at each follow-up
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)

October 1, 2026

Study Completion (Estimated)

April 1, 2031

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 (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR2052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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.

Clinical Trials on Esophageal Stricture

Clinical Trials on GIE Medical ProTractX3 TTS DCB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe