Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT06879912
Eligibility Criteria:
Pre-Operative Inclusion Criteria:
1. Age 22 years or older
2. ASA ≤ 3
3. The clinical decision has been made to perform multi-port robotic assisted surgery with da Vinci 5 with Force Feedback instruments for the study specified procedure as primary procedure prior to enrollment in the study
4. Subject or a legally authorized representative is able to provide written informed consent using the study informed consent form prior to the study
5. Subject is willing and able to comply with the study protocol requirements including follow up schedule
Pre-operative Exclusion Criteria:
* Subject receiving an emergent procedure
* Subject planned to undergo major concomitant surgery for the treatment of a different medical condition than was originally planned
* Subject with previous ipsilateral surgery (open, endoscopic or robotic) with the same surgical indication
* Subject with past or ongoing medical conditions (for example: inflammatory bowel disease) which, in the judgment of the Investigator, puts them at high risk for surgery and not appropriate for the study
* Subject is pregnant or suspected to be pregnant or breastfeeding
* Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data
* Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months
* Subject belongs to a vulnerable population.
* Subject is contraindicated for anesthesia or surgery.
* Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for the treatment of the cancer to be resected within the past 6 months
Intra-operative Exclusion Criteria
* Subject with hemodynamic or respiratory instability, which precludes the Investigator from performing the RAS.
* Subject in whom inadequate visualization makes a minimally invasive approach not feasible, as determined from the investigator assessment prior to docking the robot.
* Subject with adhesions, scarring and disease status in the body which in the opinion of the investigator limits the ability to perform the minimally invasive procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06879912
Study Brief:
Protocol Section:
NCT06879912