Neoplasms

Digestive System Diseases

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Urologic Neoplasms

Mouth Neoplasms

Urologic Diseases

Otorhinolaryngologic Diseases

Oropharyngeal Neoplasms

Laryngeal Neoplasms

Hypopharyngeal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urogenital Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Mouth Diseases

Oral Cancer

A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula

Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery

Robotic single port surgery and NOTES

This is a prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.

Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES) are emerging minimally invasive surgery techniques which can further reduce patient trauma and enhance recovery. However, the wider adoption of these techniques is hampered by the limitation of instrumentation and technical difficulties. Robotic assistance may improve surgical capabilities during single port surgery and NOTES by providing augmented motion precision and manipulation dexterity.

Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.

Design: Prospective, single center, multispecialty study consistent with a stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework.

Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the inclusion and exclusion criteria will be recruited.

Intervention: Single port surgery and transanal/transoral surgery will be performed using the novel single port robotic system.

Study Endpoints: Primary: conversion rate and perioperative complications. Secondary: operative time, blood loss, pain scores, analgesic requirement, and length of stay.

Hypothesis: The prospective study will provide important information on the feasibility, safety, and effectiveness of the novel single port robotic system in performing single port surgery and NOTES in various surgical specialties. A positive study will provide supporting evidence for continuing development of this new technology.

A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery

A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study

An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery

Complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification

Pathologic examination of the resected specimen for completeness of resection

Pathologic examination of the resected specimen for resection margins positivity

Pathologic examination of the resected specimen (malignant cases)

After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score)

After transanal surgery; using the validated Chinese version of the Fecal Incontinence Quality of Life Scale (FIQL)

After radical prostatectomy; assessed by recording the number of pads used per day

After radical prostatectomy; using the abridged version of the International Index of Erectile Dysfunction - erectile function domain score (IIEF-EF)

After nephrectomy; using renal function blood tests for urea and creatinine

After TORS; using the MD Anderson Dysphagia Inventory

After TORS; using the Voice Handicap Index (VHI) 30

Chinese University of Hong Kong

Professor of Surgery

Subjects ≥ 22 yrs requiring transoral procedures

Michael D Tricoli, BS, MBA

The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic System to visualize and access specific anatomical locations along with evaluation of the safety of the device.

A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures

A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures

Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords.

Medrobotics Corporation

Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.

daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.

da Vinci Surgical Robot Platform

Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.

Transoral Robotic Surgery

Edward J. Damrose MD, FACS

To assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the oral cavity and laryngopharynx.

In the past two decades the interest in minimally invasive techniques for transoral treatment of head and neck benign and malignant lesions has been growing due to the decreased morbidity of transoral approaches, and some surgeons have been moving away from traditional open resections. Transoral resection of neoplasms of the upper aerodigestive, by its minimally invasive nature, may afford a shorter hospitalization and recovery time for patients when compared to those patients who undergo traditional "open" surgery. In surgery of the oropharynx, hypopharynx, and larynx, transoral endoscopic surgery can provide similar outcomes in terms of local control of disease when compared to open procedures, while improving time to restoration of oral intake and shortening time to tracheostomy decannulation. Therefore, in select patients, a transoral surgical approach may afford clear advantages over traditional open approaches. Current techniques, however, are limited by the inability to attain direct line of site exposure of the lesion. Use of robot-assisted technology as a means to overcome surgical limitations, to provide surgeons with improved dexterity and precision, and to couple advanced imaging techniques with three-dimensional depth perception, may allow for the completion of transoral surgical approaches in patients for whom conventional technology has been suboptimal.

The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is FDA-approved for use in a variety of laparoscopic, thoracoscopic, cardiac, and urologic surgical procedures. This protocol will assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the oral cavity and laryngopharynx. Traditional endoscopic removal of tumors of the oropharynx and laryngopharynx is usually preferred to traditional open resection because of the decrease in morbidity and improved functional outcomes experienced by patients. The limiting step in these procedures has been exposure of, visualization of, and access to candidate tumors. The da Vinci surgical system offers the possibility of significant improvements in exposure, visualization and access to these candidate tumors with no added risk to patients. Overall this may significantly increase the number of patients who are candidates for endoscopic surgery. Alternative procedures will include traditional open surgical removal of tumors as well as traditional endoscopic removal of tumors using the microscope and CO2 laser. Open surgical approaches are reserved for patients who have large tumors unsuitable for endoscopic removal or in whom endoscopic visualization of the tumor is inadequate or impossible. The da Vinci surgical system would offer improved visualization of tumors that might otherwise be inaccessible to a traditional endoscopic approach.

Candidate patients will present with a neoplasm of the oropharynx, hypopharynx or larynx. Those patients assessed preoperatively to be candidates for transoral surgery (eg, Mallampati class I or II, normal range of neck motion, no trismus) will undergo surgery via a transoral approach to resect the tumor. This will require general anesthesia and may require postoperative hospitalization. If the tumor can be accessed, resection will proceed using the da Vinci robot. In whom the tumor cannot be accessed, resection will proceed via the conventional open approach. Pre and postoperative care will not be affected by this protocol, as it deals strictly with the manner in which the tumor is removed. Postoperative care and visits are standardized as to the nature of the tumor (eg, malignant tumors usually require follow-up visits every four to six weeks to monitor for tumor recurrence). Complications, blood loss, operative time, length of hospitalization, time to resumption of oral intake, time to decannulation, and overall local control rates will be assessed in the postoperative period.

Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract

A Pilot Study Assessing Transoral Robotic Surgery (TORS) For Oral And Laryngopharyngeal Benign And Malignant Lesions Using The da Vinci® Robotic Surgical System

Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.

Stanford University

Associate Professor of Otolaryngology

Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.

da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.

Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.

Age, Categorical

Age, Continuous

Gender

United States

Adult patients from a tertiary referral academic center

Region of Enrollment

Early termination leading to small numbers of subjects analyzed secondary to low accrual of subjects.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery	NCT03010813	Colorectal Neop... Urologic Neopla... Urologic Diseas... Nasopharyngeal ... Oropharyngeal N... Oral Neoplasms Hypopharyngeal ... Laryngeal Neopl... ENT Diseases	Robotic single ...	18 Years -	Chinese University of Hong Kong
A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures	NCT02262247	OSA Oral Disease Oropharyngeal N... Hypopharyngeal ...		22 Years -	Medrobotics Corporation
Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract	NCT00721539	Hypopharyngeal ... Laryngeal Neopl... Head and Neck C...	da Vinci Surgic... Transoral Robot...	18 Years -	Stanford University
Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract	NCT00721539	Hypopharyngeal ... Laryngeal Neopl... Head and Neck C...	da Vinci Surgic... Transoral Robot...	18 Years -	Stanford University
Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract	NCT00721539	Hypopharyngeal ... Laryngeal Neopl... Head and Neck C...	da Vinci Surgic... Transoral Robot...	18 Years -	Stanford University

Spots Global Cancer Trial Database for hypopharyngeal neoplasms