- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00627562
A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
15. marts 2016 opdateret af: Richard V. Smith, MD, Montefiore Medical Center
- Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques.
- They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.).
- The objectives are to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate.
- Secondary objective include evaluation of blood loss, length of hospital stay, complications while using the DaVinci robot system, and quality of life in subjects and historical controls undergoing similar surgery without the robot or radiation therapy.
- To evaluate recurrence, survival and other outcome data in robotic surgery patients compared with similar historical control groups (matched with respect to stage, prior and subsequent treatment, age, tumor HPV positivity) of patients who have undergone standard surgery without the robot or radiation/chemoradiation treatment as an alternative to surgery.
5. Endpoints will be compared to historical controls.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments.
The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table.
The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.).
These arms are located immediately adjacent to the patient on the operating room table.
The surgeon sits at the console and controls the position and movement of the arms and surgical tools.
The design of these tools is based upon well-established, commonly used surgical instruments.
The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device).22
Use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
71
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- At least 18 years f age
- Indications for diagnostic or therapeutic approaches for benign or malignant disease of the head and neck
- Written informed consent
Exclusion Criteria:
- Unexplained fever and/or untreated, active infection
- Pregnancy
- Previous head and neck surgery precluding transoral/endoscopic/robotic procedures
- Presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
robot assisted endoscopic head and neck surgery
|
Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
ability to adequately visualize the operative field and complete planned surgery
Tidsramme: 1 day
|
1 day
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
complication rate compared to standard endoscopic and minimally invasive procedures
Tidsramme: 1 month
|
1 month
|
blood loss compared to historical controls of endoscopic and minimally invasive procedures
Tidsramme: 1 day
|
1 day
|
quality of life at early (1-3 months) and late (one year)
Tidsramme: 1 year
|
1 year
|
number of days hospitalized immediately after surgery
Tidsramme: at discharge from hospital
|
at discharge from hospital
|
Time to recurrence of tumor or other pathology for which procedure was performed
Tidsramme: at recurrence of tumor or pathology
|
at recurrence of tumor or pathology
|
Time from start of treatment to death
Tidsramme: at time of death
|
at time of death
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Richard V Smith, MD, Montefiore Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Gourin CG, Terris DJ. Surgical robotics in otolaryngology: expanding the technology envelope. Curr Opin Otolaryngol Head Neck Surg. 2004 Jun;12(3):204-8. doi: 10.1097/01.moo.0000122309.13359.af.
- Hockstein NG, Nolan JP, O'Malley BW Jr, Woo YJ. Robot-assisted pharyngeal and laryngeal microsurgery: results of robotic cadaver dissections. Laryngoscope. 2005 Jun;115(6):1003-8. doi: 10.1212/01.WNL.0000164714.90354.7D.
- Hockstein NG, O'Malley BW Jr, Weinstein GS. Assessment of intraoperative safety in transoral robotic surgery. Laryngoscope. 2006 Feb;116(2):165-8. doi: 10.1097/01.mlg.0000199899.00479.75.
- Lobe TE, Wright SK, Irish MS. Novel uses of surgical robotics in head and neck surgery. J Laparoendosc Adv Surg Tech A. 2005 Dec;15(6):647-52. doi: 10.1089/lap.2005.15.647.
- Tanna N, Joshi AS, Glade RS, Zalkind D, Sadeghi N. Da Vinci robot-assisted endocrine surgery: novel applications in otolaryngology. Otolaryngol Head Neck Surg. 2006 Oct;135(4):633-5. doi: 10.1016/j.otohns.2006.07.003. No abstract available.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2007
Primær færdiggørelse (Faktiske)
1. juni 2014
Studieafslutning (Forventet)
1. december 2017
Datoer for studieregistrering
Først indsendt
5. februar 2008
Først indsendt, der opfyldte QC-kriterier
29. februar 2008
Først opslået (Skøn)
3. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07-03-080
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .