[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GIE Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100482368","phase-3-paclitaxel-coated-balloon-for-the-treatment-of-chronic-benign-stricture--bowel-100482368",false,"NCT05561127","Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel","PATENT-B","Inclusion Criteria:\n\n1. Age ≥ 22\n2. Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.\n3. Willing and able to complete protocol required follow up\n4. Willing and able to provide written informed consent\n5. Stricture length ≤ 5 cm\n\nExclusion Criteria:\n\n1. Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months\n2. Contraindication to endoscopy, anesthesia, or deep sedation.\n3. 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.\n4. Benign stricture due to extrinsic compression\n5. Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)\n6. Stricture complicated with abscess, fistula, perforation, leakage or varices\n7. 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\n8. 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.\n9. Received steroid injections into target stricture in the last 8 weeks\n10. Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel\n11. 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)\n12. Suspected perforation of gastrointestinal tract\n13. Active systemic infection\n14. Allergy to paclitaxel\n15. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines\n16. Chronic systemic steroid use (defined as greater than 10 mg\u002Fday) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use\n17. Condition requiring treatment in urgent setting\n18. Life expectancy of less than 24 months\n19. 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.\n20. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up","ALL","22 Years",{"count":19,"type":20},171,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.",[26],"Bowel; Stricture",[28,29,30,31],"dcb","bowel stricture","drug coated balloon","paclitaxel coated balloon","RECRUITING","2025-06-19",{"date":35,"type":36},"2025-06-25","ACTUAL",{"date":38,"type":36},"2023-11-01",{"date":40,"type":20},"2032-06-01",{"name":42,"class":43},"GIE Medical","INDUSTRY",33,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100482367","phase-3-paclitaxel-coated-balloon-for-the-treatment-of-chronic-benign-stricture--esophagus-100482367","NCT05561114","Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus","PATENT-E","Inclusion Criteria:\n\n1. Age ≥ 22 years\n2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations\n3. Ogilvie Dysphagia Score of ≥2\n4. Minimum esophageal lumen diameter \\\u003C13 mm\n5. Willing and able to complete protocol required follow-up visits\n6. Willing and able to provide written informed consent\n7. Strictures ≤5cm in total length\n8. Target benign esophageal stricture etiologies include:\n\n   1. Peptic stricture,\n   2. Schatzki's ring,\n   3. Stricture due to prior infection,\n   4. Post-procedural (e.g. ESD\u002FEMR\u002FRFA\u002FCryo) stricture\n   5. Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy\n\nExclusion Criteria:\n\n1. Two or more clinically significant (e.g. non-traversable) strictures with total length \\>5cm or unable to be treated with a single balloon.\n2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months\n3. Contraindication to endoscopy, anesthesia or deep sedation\n4. Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head\u002Fneck cancer treatment.\n5. History of diagnosis of eosinophilic esophagitis (EoE)\n6. 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\u002FPET scan) and biopsy within 6 months of enrollment.\n7. 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.\n8. Suspected perforation of gastrointestinal tract\n9. Inability to pass guidewire across stricture\n10. Active systemic infection\n11. Allergy to paclitaxel or structurally related compounds\n12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure\n13. Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use\n14. Received steroid injections into target stricture in the last 8 weeks.\n15. Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator\n16. Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function.\n17. Acute stricture condition that requires emergent procedure (e.g. immediate dilation)\n18. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc\n19. Life expectancy of less than 24 months\n20. 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\n21. Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint.\n22. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc.\n23. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy.\n24. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility.\n25. Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists)\n26. Concurrent gastric and\u002For duodenal obstruction",{"count":53,"type":20},198,[23],"To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.",[57],"Esophageal Stricture",[59,30,60,31],"esophageal stricture","DCB",{"date":35,"type":36},{"date":63,"type":36},"2023-12-01",{"date":65,"type":20},"2031-04",{"name":42,"class":43},34,""]