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New treatment option for Esophageal Stricture
Official title Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
ClinicalTrials.gov ID: NCT05561114
What this study is testing
What is GIE Medical ProTractX3 TTS DCB?
GIE Medical ProTractX3 TTS DCB is an investigational medicine, being studied as a potential treatment for esophageal stricture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join 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
You likely can't join 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 people 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...
- 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...
See the full eligibility 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
- Two or more clinically significant (e.g. non-traversable) strictures with total length \>5cm or unable to be treated with a single balloon.
- Female people 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. people with...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Irvine, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- Macon, Georgia, United States
- Chicago, Illinois, United States
- Wichita, Kansas, United States
- Louisville, Kentucky, United States
- Marrero, Louisiana, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Irvine, California, United States; Lancaster, California, United States; Los Angeles, California, United States; San Diego, California, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.