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Esophageal StricturePhase 3PATENT-ENCT05561114

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

A Phase 3 study testing GIE Medical ProTractX3 TTS DCB in people with Esophageal Stricture, run by GIE Medical at 34 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Esophageal Stricture
What is being tested?
GIE Medical ProTractX3 TTS DCB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
34 sitesUnited States
Study dates
1 Dec 2023to Apr 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
Show all 26Show fewer
  • 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
  • Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function.
  • Acute stricture condition that requires emergent procedure (e.g. immediate dilation)
  • Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc
  • Life expectancy of less than 24 months
  • 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
  • Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint.
  • Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc.
  • Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy.
  • Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility.
  • Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists)
  • Concurrent gastric and/or duodenal obstruction

Trial locations and contacts

34 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Erika Wang contact

7633605659

wange@giemedical.com

34 sites in 1 country

United States34 sites, 34 recruiting

  • University of Colorado Anschutz

    Aurora, Colorado, 80045

    Carter Stovall, carter.stovall@cuanschutz.edu

    Recruiting

  • Birmingham Gastroenterology Associates

    Birmingham, Alabama, 35209

    Tiambra Clark, tiambra.clark@objective.health

    Not yet recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Samantha Geltz, sgeltz@bwh.harvard.edu

    Recruiting

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27599

    Julia Kim, julia_kim@med.unc.edu

    Recruiting

  • Rush University

    Chicago, Illinois, 60612

    Amanda Lin, amanda_f_lin@rush.edu

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    April Goddard, april.goddard@medicine.ufl.edu

    Recruiting

  • Baylor St. Luke's Medical Center

    Houston, Texas, 75246

    Elaheh Keivani, elaheh.keivaniboroujeni@bcm.edu

    Recruiting

  • University of California, Irvine

    Irvine, California, 92697-7600

    Hector Ochoa, hcochoa@hs.uci.edu

    Recruiting

  • Borland-Groover

    Jacksonville, Florida, 32256

    Cynthia Buda, cbuda@encoredocs.com

    Recruiting

  • Gastro Care Institute

    Lancaster, California, 92534

    Ruben Vargas, rvargas@gciav.com

    Recruiting

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

    Maya Pudi, maya@auroraclinicalresearch.com

    Recruiting

  • Cedars Sinai

    Los Angeles, California, 90048

    Claudia Bancilla, liliana.bancila@cshs.org

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Angela Siegwald, angela.siegwald@louisville.edu

    Recruiting

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31210

    Elizabeth Jones, ejones@gaocg.com

    Recruiting

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

    Antoinette Hymel, ahymel@tandemclinicalresearch.com

    Recruiting

  • Research Associates of South Florida

    Miami, Florida, 33134

    Stephany Moreno, smoreno@researchassociatesfl.com

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26501

    Caitlin Regner, caitlin.regner@hsc.wvu.edu

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Larry Raber, larry.w.raber@vumc.org

    Recruiting

  • New York Presbyterian Hospital- Columbia University Medical Center

    New York, New York, 10032

    Claudia Musat, 212-305-3009, cm2065@cumc.columbia.edu

    Recruiting

  • Hillcrest Medical Research

    Orange City, Florida, 32763

    Larry Moulder, lmoulder@hillcrestmedicalresearch.com

    Recruiting

  • Orlando Health

    Orlando, Florida, 32806

    Anna Hernandez, anna.hernandez@orlandohealth.com

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Christine Gepty, christine.gepty@pennmedicine.upenn.edu

    Recruiting

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19107

    Stacey Carmody, stacy.carmody@jefferson.edu

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Manisha Verma, manisha.verma@jefferson.edu

    Recruiting

  • Rutgers University

    Piscataway, New Jersey, 08854

    Molly Stewart, molly.stewart1@rutgers.edu

    Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

    Michael Anderson

    4122288310

    Recruiting

  • TEN20 Clinical Research

    Plano, Texas, 75093

    Darian Trojacek, darian@hcbassociates.org

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97229

    Heather Katcher, katcher@ohsu.edu

    Recruiting

  • The University of Utah

    Salt Lake City, Utah, 84108

    Amy Nichols, amy.nichols@hsc.utah.edu

    Recruiting

  • San Diego Gastroenterology

    San Diego, California, 92103

    Nancy Giovanetty, nancy@sdgastro.com

    Recruiting

  • Honor Health

    Scottsdale, Arizona, 85258

    Victoria Staenglen, vstaenglen@honorhealth.com

    Recruiting

  • Swedish Medical Center

    Seattle, Washington, 98122

    Adel Islam, adel.islam@swedish.org

    Recruiting

  • Washington University

    St Louis, Missouri, 63130

    Thomas Hollander, hollandert@wustl.edu

    Recruiting

  • Kansas Gastroenterology, LLC

    Wichita, Kansas, 67226

    Jessica Wewer, jessica_wewer@ksgastro.com

    Recruiting

Other trials in United States

About this study

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

Being tested
GIE Medical ProTractX3 TTS DCB, Control
Keywords
esophageal stricture, drug coated balloon, DCB, paclitaxel coated balloon
Medical subject headings
Esophageal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIE Medical ProTractX3 TTS DCBCombination product

    Paclitaxel Coated Balloon

  • ControlOther

    Standard Endoscopic Dilation

Study groups in NCT05561114
Study groupRoleWhat they receive
GIE Medical ProTractX3 TTS DCBExperimentalThe ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Receives: Combination Product: GIE Medical ProTractX3 TTS DCB
ControlActive comparatorStandard of Care Endoscopic Dilation
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 Months Post-Procedure

  2. Primary Safety Outcome

    Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)

    Measured: 30 Days Post-Treatment

Secondary outcomes (5)

  1. Annualized Rate of Reintervention

    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.

    Measured: Annually

  2. Diameter Improvement at 6 months

    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.

    Measured: 6 Months Post-Procedure

  3. Clinical Responder Rate at 6 months

    Measured: 6 Months Post-Procedure

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

    Measured: 6 Months Post-Procedure

  5. Freedom from symptom recurrence through 6 months post-procedure

    Measured: 6 Months Post-Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2022
  2. Study start1 Dec 2023
  3. Primary completionOct 2026 (estimated)
  4. Study completionApr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05561114
Sponsor's protocol ID
PR2052
Acronym
PATENT-E
Status last verified
Jun 2025
First submitted
27 Sep 2022
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GIE Medical ProTractX3 TTS DCB in people with Esophageal Stricture, run by GIE Medical at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erika Wang (7633605659, wange@giemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Success (time frame: 6 Months Post-Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05561114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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