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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03454607
Other study ID # CRE-2017.307-T
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 4, 2018
Est. completion date November 30, 2018

Study information

Verified date October 2019
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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?


Description:

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
FREE robot
FREE robot to hold endoscope

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Shatin

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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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