Sinusitis Clinical Trial
Official title:
Safety and Feasibility Study of the Foot Controlled Robotic Endoscope Enabled Robot (FREE) in Functional Endoscopic Sinus Surgery
Verified date | October 2019 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the safety and feasibility of a Foot Controlled Robotic Endoscope Enabled Robot
(FREE) in performing functional endoscopic sinus surgery to answer the two key questions:
1. Is the FREE robot feasible to use in patients for endoscopic sinus surgery?
2. Is the FREE robot safe to use in patients for endoscopic sinus surgery?
Status | Terminated |
Enrollment | 1 |
Est. completion date | November 30, 2018 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Undergoing FESS surgery for benign pathology Exclusion Criteria: - Pregnant/ lactating female patients - Younger than 18 years of age - Cognitive impairment or unable to provide informed consent - Malignant sinus pathologies - Previous endoscopic sinus surgery - Contraindication to general anaesthesia - Untreated active infection - Non-correctable coagulopathy - Emergency Surgery |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conversion | The rate of conversions to normal holding of the endoscope | Intraoperative | |
Primary | Perioperative complications | Assessment of perioperative complications | Within 30 days postoperative | |
Secondary | Surgical outcomes | Operative time | Intraoperative and postoperative 2 weeks and 30 days | |
Secondary | Surgical outcomes | Estimated blood loss | Intraoperative and postoperative 2 weeks and 30 days | |
Secondary | Surgical Outcomes | Length of stay | Intraoperative and postoperative 2 weeks and 30 days | |
Secondary | Quality of life | The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Higher scores represent a worse outcome | Within 30 days postoperative |
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