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

NCT05561114 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: PR2052
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 34

Brief Summary

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

Conditions

Esophageal Stricture

Keywords

esophageal stricture; drug coated balloon; DCB; paclitaxel coated balloon

Outcome Measures

Primary Outcomes (2)

• Treatment Success

  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

• 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 Outcomes (5)

• Annualized Rate of Reintervention

  Annually

• Diameter Improvement at 6 months

  6 Months Post-Procedure

• Clinical Responder Rate at 6 months

  6 Months Post-Procedure

• Freedom from clinically driven target stricture reintervention through 6 months post-procedure

  6 Months Post-Procedure

• Freedom from symptom recurrence through 6 months post-procedure

  6 Months Post-Procedure

Other Outcomes (12)

• Secondary Patency

  Time between the index procedure to the second clinically driven intervention

• Technical Success

  Procedure

• Annualized rate of dilations before and after treatment

  Annually

Study Arms (2)

GIE Medical ProTractX3 TTS DCB

EXPERIMENTAL

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

Combination Product: GIE Medical ProTractX3 TTS DCB

Control

ACTIVE COMPARATOR

Standard of Care Endoscopic Dilation

Other: Control

Interventions

GIE Medical ProTractX3 TTS DCB COMBINATION_PRODUCT

Paclitaxel Coated Balloon

GIE Medical ProTractX3 TTS DCB

Control OTHER

Standard Endoscopic Dilation

Control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 22 years
• Diagnosis of a benign esophageal stricture with at least 2 previous dilations
• Ogilvie Dysphagia Score of ≥2
• Minimum esophageal lumen diameter \<13 mm
• Willing and able to complete protocol required follow-up visits
• Willing and able to provide written informed consent
• Strictures ≤5cm in total length
• Target benign esophageal stricture etiologies include:
• Peptic stricture,
• Schatzki's ring,
• Stricture due to prior infection,
• Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture
• Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy

You may not qualify if:

• Two or more clinically significant (e.g. non-traversable) strictures with total length \>5cm or unable to be treated with a single balloon.
• Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months
• Contraindication to endoscopy, anesthesia or deep sedation
• Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment.
• History of diagnosis of eosinophilic esophagitis (EoE)
• 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.
• 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.
• Suspected perforation of gastrointestinal tract
• Inability to pass guidewire across stricture
• Active systemic infection
• Allergy to paclitaxel or structurally related compounds
• Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
• Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
• Received steroid injections into target stricture in the last 8 weeks.
• Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator

Sponsors & Collaborators

• GIE Medical: lead

Study Sites (34)

Birmingham Gastroenterology Associates

Birmingham, Alabama, 35209, United States

NOT YET RECRUITING

Honor Health

Scottsdale, Arizona, 85258, United States

RECRUITING

University of California, Irvine

Irvine, California, 92697-7600, United States

RECRUITING

Gastro Care Institute

Lancaster, California, 92534, United States

RECRUITING

Cedars Sinai

Los Angeles, California, 90048, United States

RECRUITING

San Diego Gastroenterology

San Diego, California, 92103, United States

RECRUITING

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Borland-Groover

Jacksonville, Florida, 32256, United States

RECRUITING

Research Associates of South Florida

Miami, Florida, 33134, United States

RECRUITING

Hillcrest Medical Research

Orange City, Florida, 32763, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31210, United States

RECRUITING

Rush University

Chicago, Illinois, 60612, United States

RECRUITING

Kansas Gastroenterology, LLC

Wichita, Kansas, 67226, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

Sierra Clinical Research

Las Vegas, Nevada, 89106, United States

RECRUITING

Rutgers University

Piscataway, New Jersey, 08854, United States

RECRUITING

New York Presbyterian Hospital- Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97229, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Einstein Medical Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Baylor St. Luke's Medical Center

Houston, Texas, 75246, United States

RECRUITING

TEN20 Clinical Research

Plano, Texas, 75093, United States

RECRUITING

The University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26501, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Erika Wang

CONTACT

7633605659; wange@giemedical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: December 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2031
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)