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A randomized controlled trial
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This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.
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Inclusion Criteria
Exclusion Criteria:
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Interventional model
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50 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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