Here is the design of a clinical trial:

Official Title: A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury

Included conditions:
- Injury of Nerves at Wrist and Hand Level

Study Armgroups:
- {'label': 'Polynerve', 'type': 'EXPERIMENTAL', 'description': 'Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve.', 'interventionNames': ['Device: Polynerve']}

Interventions:
- {'type': 'DEVICE', 'name': 'Polynerve', 'description': 'Polymer biomaterial nerve conduit', 'armGroupLabels': ['Polynerve']}

Primary Outcomes:
- {'measure': 'Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications', 'description': 'To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand', 'timeFrame': '1 year'}

Please estimate the sample size based on the assumption: 
No specific assumptions on significance level, power, or missing/dropout rate were made.
Sample size
        As this was a phase I study, primarily assessing safety of the device, a pragmatic decision on achievable recruitment numbers at a single centre who would be able to complete 12-months follow-up was made, and no formal power calculations were performed. The trial will recruit 17 participants over 12 months at an intended rate of approximately 1 to 2 participants per month. All participants fitting the eligibility criteria will be recruited.