An Observational Study: Surgeon experience using the Novel Pulse Control Setting on Sonopet including video demonstration of use.
M
Mitesh Shah, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
2 Locations
Brief description of study
What is the purpose of this study?
The objective is to record the surgeons’ comparison of the software upgrade to the traditional setting in terms of control, preservation of critical structures, ease of changing settings and visibility of tissue removal. These characteristics will be captured in the post-operative survey and rated as observed/not observed in the video analysis survey. The surgery and use of both settings (traditional, pule) is SOC. Both settings are available, and it is the surgeon’s choice as to which setting to use. This is not dictated by the protocol, but rather a clinically based decision and the surgeon’s choice; “Sonopet iQ® traditional and new Pulse Control settings will be used as appropriate during the surgery and at the discretion of the surgeon. The surgeon will be comparing the current option to an option that gives various options in pulse control at the same power setting.”
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- For the patients, study introduction and consenting will take place either over the telephone or in person, in a location that provides privacy to the potential subject. The physician may introduce the study to the patient, but consenting would be done by research personnel who will be alerted to the potential; study subject by the physician. There is no study intervention, but the intra-operative video recording will take place in the operating room (Dr. Shah routinely video records his surgeries).
- Surgeons: Surgeons who have participated in the surgeries will be given an Study Information Sheet (SIS) to read prior to reviewing the video recording and completing the surgeon survey. They will do this at IU Health Methodist Hospital in proximity to the operating room where the surgery occurred. The location will include private space for the surgeons to complete the survey.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: CNS tumor, cerebellopontine angle tumor, meningioma, schwannoma, neurofibroma chordoma, spinal cord tumor
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria
1. ≥ 18 years old at the time of informed consent.
2. Ability to provide written informed consent and HIPAA authorization, or a legally authorized representative is available to provide written informed consent and HIPAA authorization.
3. Diagnosed with any type of the following CNS tumors and has a surgical plan: 1) cerebellopontine angle tumors; 2) meningioma; 3) schwannoma; 4) neurofibroma chordoma; or 5) spinal cord tumor; 6) any tumor removal requiring boney removal around critical structures like the IAC or anterior clinoid.
Exclusion Criteria
1. Patients younger than 18 years old and/or not having a CNS tumor resection plan.2. Pregnant women and non-English speaking patients are excluded.
Updated on
01 Aug 2024.
Study ID: SNEU-STRYKER-SONOPET, 15446;18189
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