Skip to main content
SpringerLink
Log in

A prospective, feasibility study to evaluate the efficacy and usability of a novel drivable endoscope in patients with chronic rhinosinusitis

  • Rhinology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Purpose

To carry out a pilot study to evaluate the efficacy of a novel, drivable endoscope (the Peregrine™ Drivable ENT Scope), compared to standard rigid endoscopes in the access, visualization, and irrigation of the paranasal sinus anatomy.

Methods

A prospective, multi-center, feasibility study was conducted on seventeen subjects who underwent primary functional endoscopic sinus surgery and were evaluated with the drivable endoscope and standard, rigid endoscopes (0°, 30° and 70°, as applicable). A CT scan was available for image guidance, as needed. The primary efficacy endpoint was the ability to access and visualize sinonasal anatomic landmarks. Secondary endpoints included device usability, as measured by a usability questionnaire given to surgeons postoperatively; the device’s ability to irrigate the sinuses and patient reports of tolerability and pain during postoperative procedures.

Results

The drivable endoscope success rate in visualizing all paranasal sinus anatomic landmarks was 55.6% better than the standard rigid endoscopes: 98.3% (178/181) versus 42.7% (76/178); p < 0.001. Surgeons rated scores of over 4 (on a 1–5 scale) for the usability of the drivable endoscope to enter the maxillary, frontal and sphenoid sinuses. The ability to irrigate the sinuses using the drivable endoscope was given a mean score of 4.3, and image quality was given a mean score of 3.4. The three patients evaluated postoperatively reported low pain and high tolerability scores with the drivable endoscope.

Conclusions

These preliminary results indicate that the drivable endoscope is effective, easy to use and highly tolerable in sinonasal endoscopy.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Carniol ET, Vázquez A, Patel TD, Liu JK, Eloy JA (2017) Utility of intraoperative flexible endoscopy in frontal sinus surgery. Allergy Rhinol (Providence) 8(2):81–84. https://doi.org/10.2500/ar.2017.8.0205

    Article  Google Scholar 

  2. Pleis J, Lucas J (2009) Summary health statistics for U.S. adults: National Health Interview Survey. Vital Health Stat 240:1–159

    Google Scholar 

  3. Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A et al (2011) Chronic rhinosinusitis in Europe—an underestimated disease. A GA(2)LEN study. Allergy 66(9):1216–1223. https://doi.org/10.1111/j.1398-9995.2011.02646.x

    Article  CAS  PubMed  Google Scholar 

  4. Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F et al (2012) EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology 50(1):1–12. https://doi.org/10.4193/Rhino12.000

    Article  PubMed  Google Scholar 

  5. Gliklich R, Metson R (1995) The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg 113:104–109. https://doi.org/10.1016/S0194-5998(95)70152-4

    Article  CAS  PubMed  Google Scholar 

  6. Kuhn FA (2006) An integrated approach to frontal sinus surgery. Otolaryngol Clin North Am 39(3):437–461. https://doi.org/10.1016/j.otc.2006.01.008

    Article  PubMed  Google Scholar 

  7. Patel VS, Choby G, Shih LC, Patel ZM, Nayak JV, Hwang PH (2018) Equivalence in outcomes between Draf 2B vs Draf 3 frontal sinusotomy for refractory chronic frontal rhinosinusitis. Int Forum Allergy Rhinol 8(1):25–31. https://doi.org/10.1002/alr.22032

    Article  PubMed  Google Scholar 

  8. Shargorodsky J, Bhattacharyya N (2013) What is the role of nasal endoscopy in the diagnosis of chronic rhinosinusitis? Laryngoscope 123(1):4–6. https://doi.org/10.1002/lary.23385

    Article  PubMed  Google Scholar 

  9. Ramakrishnan VR, Orlandi RR, Citardi MJ et al (2013) The use of image-guided surgery in endoscopic sinus surgery: an evidence-based review with recommendations. Int Forum Allergy Rhinol 3(3):236–241. https://doi.org/10.1002/alr.21094

    Article  PubMed  Google Scholar 

  10. Gamrot-Wrzoł M, Sowa P, Lisowska G, Ścierski W, Misiołek M (2017) Risk factors of recurrence and malignant transformation of sinonasal inverted papilloma. Biomed Res Int 2017:9195163. https://doi.org/10.1155/2017/9195163

    Article  PubMed  PubMed Central  Google Scholar 

  11. Bugter O, Monserez DA, van Zijl FVWJ, Baatenburg de Jong RJ, Hardillo JA (2017) Surgical management of inverted papilloma; a single-center analysis of 247 patients with long follow-up. J Otolaryngol Head Neck Surg 46(1):67. https://doi.org/10.1186/s40463-017-0246-7

    Article  PubMed  PubMed Central  Google Scholar 

  12. Lisan Q, Laccourreye O, Bonfils P (2016) Sinonasal inverted papilloma: from diagnosis to treatment. Eur Ann Otorhinolaryngol Head Neck Dis 133(5):337–341. https://doi.org/10.1016/j.anorl.2016.03.006

    Article  CAS  PubMed  Google Scholar 

  13. Kasbekar AV, Swords C, Attlmayr B, Kulkarni T, Swift AC (2018) Sinonasal papilloma: what influences the decision to request a magnetic resonance imaging scan? J Laryngol Otol 132(7):584–590. https://doi.org/10.1017/S0022215118000804

    Article  CAS  PubMed  Google Scholar 

  14. Trimarchi M, Tomazic PV, Bertazzoni G, Rathburn A, Bussi M, Stammberger H (2014) Video endoscopic oro-nasal visualisation of the anterior wall of maxillary sinus: a new technique. Acta Otorhinolaryngol Ital 34(4):259–263

    CAS  PubMed  PubMed Central  Google Scholar 

  15. Varshney R, Zawawi F, Tewfik MA, Frenkiel S (2013) Endoscopy—chapter 8: an advancement in sinus and skull base surgery, endoscopy, somchai amornyotin. IntechOpen. https://doi.org/10.5772/52749, https://www.intechopen.com/books/endoscopy/endoscopy-an-advancement-in-sinus-and-skull-base-surgery

  16. Messerklinger W (1994) Background and evolution of endoscopic sinus surgery. Ear Nose Throat J 73(7):449–450

    Article  CAS  PubMed  Google Scholar 

  17. Sillers MJ, Melroy CT (2013) In-office functional endoscopic sinus surgery for chronic rhinosinusitis utilizing balloon catheter dilation technology. Curr Opin Otolaryngol Head Neck Surg 21(1):17–22. https://doi.org/10.1097/MOO.0b013e32835c05e1

    Article  PubMed  Google Scholar 

  18. Castelnuovo P, Valentini V, Giovannetti F, Bignami M, Cassoni A, Iannetti G (2008) Osteomas of the maxillofacial district: endoscopic surgery versus open surgery. J Craniofac Surg 19(6):1446–1452. https://doi.org/10.1097/SCS.0b013e31818b417d

    Article  PubMed  Google Scholar 

  19. Glass D, Amedee RG (2011) Allergic fungal rhinosinusitis: a review. Ochsner J 11(3):271–275

    PubMed  PubMed Central  Google Scholar 

  20. Lund VJ, Clarke PM, Swift AC, McGarry GW, Kerawala C, Carnell D (2016) Nose and paranasal sinus tumours: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol 130(S2):S111–S118. https://doi.org/10.1017/S0022215116000530

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

The authors would like to thank Eran Choman (independent) for performing the statistical analysis in this study and Dr. Ruth Moont and Dr. Ronell Klingman for their assistance in writing and editing the manuscript.

Funding

This study was funded by 3NT Medical Ltd., Rosh Ha’ayin, Israel.

Author information

Authors and Affiliations

  1. Department of Otorhinolaryngology, Ghent University Hospital, C Heymanslaan 10, Entrance 69, 9000, Ghent, Belgium

    Thibaut Van Zele & Philippe Gevaert

  2. Rabin Medical Center, Petach Tikva, Israel

    Ethan Soudry

  3. Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

    Ethan Soudry

  4. Assuta Medical Center, Tel Aviv-Yafo, Israel

    Roee Landsberg

Authors
  1. Thibaut Van Zele
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ethan Soudry
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Roee Landsberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Philippe Gevaert
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Philippe Gevaert.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Informed consent

The research involved human participants who all provided written informed consent.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 15 kb)

Supplementary file2 (MP4 9397 kb)

Supplementary file3 (MP4 37283 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Van Zele, T., Soudry, E., Landsberg, R. et al. A prospective, feasibility study to evaluate the efficacy and usability of a novel drivable endoscope in patients with chronic rhinosinusitis. Eur Arch Otorhinolaryngol 276, 2499–2505 (2019). https://doi.org/10.1007/s00405-019-05535-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00405-019-05535-0

Keywords

Search

Navigation