Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
9 participants
INTERVENTIONAL
2019-02-24
2024-12-31
Brief Summary
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Detailed Description
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Up to 30 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCB Treatment
Stricture patients treated by DCB
GIE Drug Coated Balloon
The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.
Interventions
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GIE Drug Coated Balloon
The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.
Eligibility Criteria
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Inclusion Criteria
2. Benign esophageal stricture with diameter less than 10 mm (barium esophagram).
3. Dysphagia score of 2 to 4 (Ogilvie Dysphagia Score).
4. Recurrent stricture after at least 2 previous balloon/bougie dilation or stricturotomy sessions.
5. Stricture total length ≤ 7 cm. Tandem or adjacent strictures are allowed if the strictures are caused by the same underlining disease.
6. Ability to undergo periodic endoscopic follow-up.
7. Voluntary participation and provided written informed consent.
Exclusion Criteria
2. Contraindication to endoscopy, anesthesia or deep sedation.
3. Benign esophageal stricture due to extrinsic esophageal compression.
4. Currently required chest radiation therapy.
5. Malignant esophageal stricture.
6. Stricture total length \> 7 cm or esophageal strictures at multiple locations where the total stricture length exceeds 7 cm
7. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, etc.
8. Active erosive esophagitis.
9. Present esophageal ulceration, perforation, leak, fistula, or varices.
10. Concurrent gastric and/or duodenal obstruction.
11. Active systemic infection.
12. Allergy to paclitaxel or any components of the delivery system.
13. Severe coagulation disorders or current use of anticoagulant for comorbidities.
14. Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
15. Received steroid injections into target stricture in the last 4 weeks
16. Intolerant to proton pump inhibitors.
17. Life expectancy of less than 12 months.
18. Unwilling or unable to comply with the follow-up study requirements.
19. Lacking capacity to provide informed consent.
20. 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, recent laparotomy, pharyngeal or cervical deformity, etc.
21. Currently participation in another pre-market drug or medical device clinical study.
18 Years
80 Years
ALL
No
Sponsors
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GIE Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Adventista Hospital
Asunción, , Paraguay
Countries
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Other Identifiers
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PR2001
Identifier Type: -
Identifier Source: org_study_id
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