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Foot Controlled Robotic Endoscope Enabled Robot FESS

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ClinicalTrials.gov Identifier: NCT03454607
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jason Chan, Chinese University of Hong Kong

Brief 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?

Condition or disease Intervention/treatment Phase
Sinusitis Polyp of Nasal Sinus Device: FREE robot Not Applicable

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety and Feasibility Study of the Foot Controlled Robotic Endoscope Enabled Robot (FREE) in Functional Endoscopic Sinus Surgery
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: FREE robot
Patients undergoing sinus surgery with the FREE robot
Device: FREE robot
FREE robot to hold endoscope




Primary Outcome Measures :
  1. Conversion [ Time Frame: Intraoperative ]
    The rate of conversions to normal holding of the endoscope

  2. Perioperative complications [ Time Frame: Within 30 days postoperative ]
    Assessment of perioperative complications


Secondary Outcome Measures :
  1. Surgical outcomes [ Time Frame: Intraoperative and postoperative 2 weeks and 30 days ]
    Operative time

  2. Surgical outcomes [ Time Frame: Intraoperative and postoperative 2 weeks and 30 days ]
    Estimated blood loss

  3. Surgical Outcomes [ Time Frame: Intraoperative and postoperative 2 weeks and 30 days ]
    Length of stay

  4. Quality of life [ Time Frame: Within 30 days postoperative ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454607


Contacts
Contact: Cherrie Ng +85235051409 cherrieng@ent.cuhk.edu.hk

Locations
Hong Kong
The Chinese University of Hong Kong Recruiting
Shatin, Hong Kong
Contact: Cherrie Ng         
Sponsors and Collaborators
Chinese University of Hong Kong

Responsible Party: Jason Chan, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03454607     History of Changes
Other Study ID Numbers: CRE-2017.307-T
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jason Chan, Chinese University of Hong Kong:
FREE
Robotic

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases