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New treatment option for Bowel; Stricture
Official title Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
ClinicalTrials.gov ID: NCT05561127
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 bowel; 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 determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel 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
- 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
You likely can't join if
- Female people 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...
- 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
See the full eligibility 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
- Female people 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...
- 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)...
- 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...
- 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...
- Current participation in another pre-market drug or medical device clinical study unless in long term follow-up
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Piscataway, New Jersey, United States
- New York, New York, United States
+ 8 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 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 and 22 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.