Scottsdale, AZNCT05561114Now EnrollingIRB Ready

Esophageal Stricture Clinical Trial in Scottsdale, AZ

Access cutting-edge esophageal stricture treatment through this phase 3 clinical trial at a research site in Scottsdale. Study-provided care at no cost to qualified participants.

Sponsored by GIE Medical

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Expert Care in Scottsdale

Access esophageal stricture specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related esophageal stricture treatment provided free

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Check if you qualify for this esophageal stricture clinical trial in Scottsdale, AZ

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Scottsdale

    Convenient for AZ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Scottsdale site if eligible
  4. 4Begin participation

About This Esophageal Stricture Study in Scottsdale

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

Sponsor: GIE Medical

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

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
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Scottsdale?

Yes, this clinical trial (NCT05561114) has an active research site in Scottsdale, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Esophageal Stricture Treatment Options in Scottsdale, AZ

If you're searching for esophageal stricture treatment options in Scottsdale, AZ, this clinical trial (NCT05561114) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Scottsdale research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced esophageal stricture specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all esophageal stricture clinical trials near you to find additional studies recruiting in your area.

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