An interventional study of FREE robot in Sinusitis and Polyp of Nasal Sinus, sponsored by Chinese University of Hong Kong. Terminated at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Other
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:
Through previous cadaver experiments we have demonstrated and experimentally validated a new foot-controlled robotic endoscope holder prototype that allows the surgeon to directly manipulate surgical instruments with both hands at all times. The conducted ex-vivo cadaver test, corroborated the feasibility of the robotic prototype. However the next step requires further clinical trials to evaluate its use in endoscopic sinus surgery in patients that is the purpose of this study
Exclusion Criteria:
Patients undergoing sinus surgery with the FREE robot
Device: FREE robot
FREE robot to hold endoscope
Conversion
The rate of conversions to normal holding of the endoscope
Time frame: Intraoperative
Perioperative complications
Assessment of perioperative complications
Time frame: Within 30 days postoperative
Surgical outcomes
Operative time
Time frame: Intraoperative and postoperative 2 weeks and 30 days
Surgical outcomes
Estimated blood loss
Time frame: Intraoperative and postoperative 2 weeks and 30 days
Surgical Outcomes
Length of stay
Time frame: Intraoperative and postoperative 2 weeks and 30 days
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
Time frame: Within 30 days postoperative
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong