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Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel

Study acronym: PATENT-B
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Sep 1, 2026 to Dec 1, 2027
    • Study completion date: Mar 1, 2029 to Jun 1, 2032
    v11
  2. Study sites: 32 to 33v10
  3. Study sites: 31 to 32v9
  4. Study sites: 21 to 31v8
  5. Study sites: 16 to 21v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Sep 1, 2024 to Sep 1, 2026v6
  2. Study sites: 2 to 16v5
  3. Study sites: 1 to 2v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 65 words
    • Site details revised
    v3
  5. Study Status, Contacts/Locationsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Trial Details
NCT Number NCT05561127
Lead Sponsor GIE Medical
Conditions
(from sponsor)		 Bowel; Stricture
Related terms Color Vision Defects, Constriction, Pathologic
Enrollment 171 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov