Safety and Feasibility of ActivSightTM in Human (NCT04633512) | Clinical Trial Compass
UnknownNot Applicable
Safety and Feasibility of ActivSightTM in Human
United States67 participantsStarted 2020-11-17
Plain-language summary
ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively.
Primary Objective: To determine safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery.
Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients age \>= 18 years old undergoing laparoscopic or robot assisted intestinal anastomoses, or all patients age \>= 18 years old who are planned for laparoscopic cholecystectomy; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent.
* Diagnosis:
* All patients with a clinical suspicion and diagnosis of benign or malignant, small or large bowel lesions requiring surgical resection.
* All patients with clinical suspicion and diagnosis of symptomatic cholelithiasis or cholecystitis planned for cholecystectomy.
* Typical imaging as per standard workup findings including US, CT and/or MRI. Plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis.
* Any bariatric patients undergoing gastric sleeve or bypass.
* Any pediatric patient undergoing laparotomy for necrotizing enterocolitis
* Location of pathology or resected segment:
* Target lesions can be located in any fore-, mid- or hindgut segments requiring reconstruction and anastomoses.
* Prior therapy:
* Patients with prior surgery are eligible for enrollment.
* Laboratory:
* Hemoglobin \> 9 g/dL
* Platelet count ≥75,000/μL (may receive transfusions)
* Normal prothrombin time, tested prothrombin, and international normalized ratio \< 1.5 x upper limit of normal (ULN) (including patients on prophylactic ant…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events in 28 days following use of ActivSightTM
Timeframe: 28 days
2
Preparation time of ActivSightTM.
Timeframe: 1 day
3
Latency of display of ActivSightTM.
Timeframe: 1 day
4
Resolution of display of ActivSightTM.
Timeframe: 1 day
5
Specificity of display of ActivSightTM.
Timeframe: 1 day
6
Usability of ActivSightTM by surgeon, as quantified by Likert scale.
Timeframe: 1 day
7
Support personnel satisfaction with ActivSightTM, as quantified by Likert scale.