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RecruitingPhase 3

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

GIE Medical · NCT05561127

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
171
US sites recruiting
32
Study start
November 1, 2023
Record last updated
June 25, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

Being studied: GIE Medical ProTractX3 TTS DCB; Control

Conditions: Bowel; Stricture

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Age ≥ 22
  • Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
  • Willing and able to complete protocol required follow up
  • Willing and able to provide written informed consent
  • Stricture length ≤ 5 cm

Exclusion Criteria

  • Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
  • Contraindication to endoscopy, anesthesia, or deep sedation.
  • Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator.
  • Benign stricture due to extrinsic compression
  • Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
  • Stricture complicated with abscess, fistula, perforation, leakage or varices
  • Stricture segment has moderate to severe active inflammation at the time of treatment. Moderate to severe inflammation is defined as any one of; ulcers >0.5cm in diameter, ulcerated surface >10%, affected (inflamed) surface >50%, marked erythema, absent vascular pattern, significant friability, or erosions
  • Multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be ≤5cm) NOTE: Clinically significant strictures include those that are unable to be passed by the endoscope.
  • Received steroid injections into target stricture in the last 8 weeks
  • Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel
  • Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer)
  • Suspected perforation of gastrointestinal tract
  • Active systemic infection
  • Allergy to paclitaxel
  • Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
  • Chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
  • Condition requiring treatment in urgent setting
  • 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, etc.
  • Current participation in another pre-market drug or medical device clinical study unless in long term follow-up

Recruiting US locations

  • Honor Health

    Scottsdale, AZ 85258

    Site contact: Victoria Staenglen · vstaenglen@honorhealth.com

  • University of California, Irvine

    Irvine, CA 92697-7600

    Site contact: Hector Ochoa · hcochoa@hs.uci.edu

  • Gastro Care Institute

    Lancaster, CA 93534

    Site contact: Ruben Vargas · rvargas@gciav.com

  • Cedars Sinai

    Los Angeles, CA 90048

    Site contact: Claudia Bancilla · liliana.bancila@cshs.org

  • San Diego Gastroenterology

    San Diego, CA 92103

    Site contact: Nancy Giovanetty · nancy@sdgastro.com

  • University of Colorado Anschutz

    Aurora, CO 80045

    Site contact: Carter Stovall · 303.724.9228 · carter.stovall@cuanschutz.edu

  • University of Florida

    Gainesville, FL 32610

    Site contact: April Goddard · 352-273-9472 · april.goddard@medicine.ufl.edu

  • Borland-Groover

    Jacksonville, FL 32256

    Site contact: Cynthia Buda · 904-680-0871 · cbuda@encoredocs.com

  • Research Associates of South Florida

    Miami, FL 33134

    Site contact: Nicole Rieth · nrieth@researchassociatesfl.com

  • Orlando Health

    Orlando, FL 32806

    Site contact: Anna Hernandez · (321) 841-6649 · anna.hernandez@orlandohealth.com

  • Orlando Health

    Orlando, FL 32806

    Site contact: Anna Hernandez · anna.hernandez@orlandohealth.com

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, GA 31210

    Site contact: Elizabeth Jones · 4177182100 · ejones@gaocg.com

  • Rush University

    Chicago, IL 60612

    Site contact: Maria Guzman · maria_E_guzman@rush.edu

  • Kansas Gastroenterology, LLC

    Wichita, KS 67226

    Site contact: Jessica Wewer · jessica_wewer@ksgastro.com

  • University of Louisville

    Louisville, KY 40202

    Site contact: Angela Siegwald · (502) 852-2043 · angela.siegwald@louisville.edu

  • Tandem Clinical Research

    Marrero, LA 70072

    Site contact: Antoinette Hymel · (504) 934-8424 · ahymel@tandemclinicalresearch.com

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Samantha Geltz · sgeltz@bwh.harvard.edu

  • Washington University

    St Louis, MO 63130

    Site contact: Thomas Hollander · hollandert@wustl.edu

  • Rutgers University

    Piscataway, NJ 08854

    Site contact: Molly Stewart · molly.stewart1@rutgers.edu

  • New York Presbyterian Hospital- Columbia University Medical Center

    New York, NY 10027

    Site contact: Claudia Musat · 212-305-3009 · cm2065@cumc.columbia.edu

  • Lenox Hill Hospital

    New York, NY 10075

    Site contact: Rachel Maggi · : (212) 434-3346 · rmaggi@northwell.edu

  • University of North Carolina

    Chapel Hill, NC 27599-1350

    Site contact: Emily English · emily_english@med.unc.edu

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Christine Gepty · 215-349-8527 · christine.gepty@pennmedicine.upenn.edu

  • Einstein Medical Center

    Philadelphia, PA 19107

    Site contact: Stacey Carmody · stacy.carmody@jefferson.edu

  • Thomas Jefferson University

    Philadelphia, PA 19107

    Site contact: Manisha Verma · (267) 234-1528 · manisha.verma@jefferson.edu

  • Allegheny Health Network

    Pittsburgh, PA 15212

    Site contact: Brianna Smith · 4122288310 · brianna.smith@ahn.org

  • Vanderbilt University Medical Center

    Nashville, TN 27232

    Site contact: Larry Raber · larry.w.raber@vumc.org

  • Baylor St. Luke's Medical Center

    Houston, TX 77030

    Site contact: Elaheh Boroujeni · elaheh.keivaniboroujeni@bcm.edu

  • The University of Utah

    Salt Lake City, UT 84108

    Site contact: Amy Nichols · 8015879050 · amy.nichols@hsc.utah.edu

  • Virginia Mason

    Seattle, WA 98101

    Site contact: Emily Chesterfield · emily.chesterfield@commonspirit.org

  • Swedish Medical Center

    Seattle, WA 98122

    Site contact: Adel Islam · 206.386.3201 · adel.islam@swedish.org

  • West Virginia University

    Morgantown, WV 26501

    Site contact: Caitlin Regner · caitlin.regner@hsc.wvu.edu

Study contacts (from the official record)

  • Erika Wang · 0000000000 · wange@giemedical.com
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN… (NCT05561127) | Bored Studies