Medical Device Usage and Evaluation for Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA
Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)+2 More
Medical Device Usage and Evaluation - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether virtual reality 3D-surgery modeling can improve the quality of head and neck cancer surgery.

See full description

Eligible Conditions

  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Study Objectives

This trial is evaluating whether Medical Device Usage and Evaluation will improve 2 primary outcomes and 2 secondary outcomes in patients with Squamous Cell Carcinoma Head and Neck Cancer (HNSCC). Measurement will happen over the course of Completion of surgical resection.

Completion of surgical resection
Physician task load burden
Proportion of successful Virtual Reality/3 dimensional- Case Enhancement Protocols (VR3D-CEPs) to the proportion of VR3D-CEP attempts
Quality of existing interdisciplinary intraoperative communication
Robotic surgical difficulty

Trial Safety

Safety Progress

1 of 3

Other trials for Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Trial Design

2 Treatment Groups

Arm II (standard treatment)
1 of 2
Arm I (VR/3D-CEPs, standard treatment)
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Medical Device Usage And Evaluation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm I (VR/3D-CEPs, standard treatment)Prior to surgery (day 0-13), patients undergo virtual reality 3D tumor resection via VR/3D-CEPs. Patients' pre-surgical CT scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29 and a 3D model of true tumor is created and imported into the virtual reality environment.
Arm II (standard treatment)Prior to surgery (day 0-13), patients' pre-surgical CT scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2021
Completed Phase 2
~400

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: completion of surgical resection
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly completion of surgical resection for reporting.

Closest Location

Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosed with head and neck squamous cell carcinoma of the mucosa
Receiving treatment at Thomas Jefferson University - Center City by a fellowship-trained HNC surgeon
Age > 18
Provide signed written informed consent document

Patient Q&A Section

Is medical device usage and evaluation safe for people?

"The types of health devices used by older adults have been appraised using various instruments. There are many concerns regarding the safety of medical device usage and evaluation. They must be assessed before usage because they may affect the outcome of surgery, whether surgery is needed at all, and the extent of surgery required." - Anonymous Online Contributor

Unverified Answer

What is the latest research for head neoplasms?

"The American Cancer Society (ACS) estimates that there will be 200,000 Americans diagnosed with HNSCC in 2014. As the number of patients diagnosed with early stage HNSCC continues to grow, so does the importance of continuing to improve outcomes for these patients. There have been many advances made over the past 10 years in the field of HNSCC. These include improvements in detection, improved staging techniques, better prediction tools, and improved treatment options. However, the survival rate has not changed significantly from its dismal 1968 level. It remains a challenge for all providers to further improve patient outcomes." - Anonymous Online Contributor

Unverified Answer

What does medical device usage and evaluation usually treat?

"The majority of respondents treat medically device usage through direct patient care and consultation. Although this study is limited by the small sample size, the results presented here highlight the need for further research regarding educational and informational interventions to improve the understanding of patient perceptions about medical devices and their use. In addition, our findings suggest the potential for educational efforts to improve patient comprehension of these devices, thereby improving patient satisfaction and adherence with medical device treatment." - Anonymous Online Contributor

Unverified Answer

How many people get head neoplasms a year in the United States?

"There are an estimated 11,000 cases of primary brain tumors and 2,500 cases of intracranial metastases annually in the United States. Although the number of cases may appear large, only 6,000 are expected to have a fatal outcome each year. This article provides background information on the incidence of primary brain tumors and metastases in the USA and discusses the role of imaging and staging techniques in their management." - Anonymous Online Contributor

Unverified Answer

Can head neoplasms be cured?

"The present study suggests that the effectiveness of radiotherapy for head tumors may depend on the tumor site. To improve the efficacy of radiation therapy, larger randomized controlled trials are needed to further evaluate the therapeutic effects of radiosurgery and brachytherapy for head neoplasms." - Anonymous Online Contributor

Unverified Answer

How does medical device usage and evaluation work?

"Results from a recent paper provides an overview of current practices and offers a blueprint for establishing baseline data on the safety and effectiveness of the Medical Device Usage Evaluation (MDUE) Program to detect and prevent adverse events associated with devices used in pediatric and adult pediatric surgery." - Anonymous Online Contributor

Unverified Answer

What is head neoplasms?

"There are many types of head neoplasms, and their pathological features and biological properties vary according to location. Simple classification methods for head and neck tumors were not sufficient enough. Head and neck tumor classification system was developed based on the histopathology characteristics of head and neck tumors. The system was used to classify head and neck tumors into different types." - Anonymous Online Contributor

Unverified Answer

How serious can head neoplasms be?

"The guideline grade may help us to decide whether we should perform surgery or not. No one grading system can achieve complete agreement between experts, so there is no single criterion that will reflect the seriousness of the malignancy. We need to look at the entire case history including clinical presentation, imaging findings, and microscopic evidence, as well as knowledge of the histopathologic features and immunohistochemistry profiles." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for head neoplasms?

"The patients who were satisfied with their choice of therapy tended to have better outcomes. The authors concluded that, in general, the patients' selection of physicians and medical centers can influence their outcome." - Anonymous Online Contributor

Unverified Answer

Has medical device usage and evaluation proven to be more effective than a placebo?

"Data from a recent study show that patient satisfaction increases significantly with the use of the device compared to the control group using the device at the same time interval. In addition, the cumulative duration of use of the device was found to have been associated with better patient satisfaction, especially for head and neck cancer patients." - Anonymous Online Contributor

Unverified Answer

How quickly does head neoplasms spread?

"The time it takes for a head neoplasm to grow from one site to another is influenced by both the nature of the tumour and the host's immunity. It has been estimated that tumors can take up to four years to develop into metastases. When this happens, the patient can expect to be suffering from the systemic consequences of their disease. Clinical trials of immunotherapy agents for metastatic neuroendocrine tumors are ongoing. These trials will help determine if immune therapies can halt or even reverse progression of metastatic neuroendocrine tumors." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) by sharing your contact details with the study coordinator.