Acute CholecystitisNCT04633512
Safety and Feasibility of ActivSightTM in Human
A study testing ActivSight in people with Acute Cholecystitis and Colorectal Cancer, run by Activ Surgical at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Cholecystitis, Colorectal Cancer, Diverticulitis, Colonic
- What is being tested?
- ActivSight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Nov 2020to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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 anticoagulation)
- Renal function: Age-adjusted normal serum creatinine derived from Schwartz formula for estimating glomerular filtration rate by the Centers for Disease Control (CDC) or a creatinine clearance ≥60 mL/min/1.73 m2 for safe
- Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination.
Who cannot join
- There is no exclusion criteria for ActivSightTM for gastrointestinal resection.
- Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, and pregnancy.
- Patients eligible for cholecystectomy, exclusion criteria include known allergy to iodides; known history of cholangitis, pancreatitis, prior common bile duct injury, coagulopathy or known, preexisting liver disease; pregnancy or breast-feeding; or being of reproductive age with pregnancy possible and not ruled out.
- Patients currently in any investigational agents.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaleida Health, University of Buffalo
Buffalo, New York, 14203
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
Memorial Hermann Sugar Land Hospital
Sugar Land, Texas, 77479
About this study
Official title: Safety and Feasibility of ActivSightTM Laser Speckle Imaging in Visualization of Tissue Perfusion and Vasculature in Human
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).
Read the detailed description
Design:
- This is a feasibility study designed to evaluate safety and feasibility of ActivSightTM in gastrointestinal anastomoses and cholecystectomy.
- Safety will be determined through clinical assessments and evaluation of any adverse event.
- Feasibility will be determined through technically successful completion of intended visualization.
- Assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to ICG-based visualization and usability.
- Patients outcome and follow up to Postoperative day 28 will be monitored for clinical outcome.
- Target enrollment for the assessment of 80 patients; 52 evaluating intestinal anastomoses cases (including bariatric and colorectal cases); and 28 evaluating laparoscopic cholecystectomy. Stopping rules are triggered following the first 6 patients and a comparison group 6 patients in ICG-based treatment.
- Conditions
- Acute Cholecystitis, Colorectal Cancer, Diverticulitis, Colonic, Obesity, Morbid, Inflammatory Bowel Diseases
- Being tested
- ActivSight
- Keywords
- laparoscopic, robot assisted surgery, gastrointestinal anastomoses, cholecystectomy, colorectal surgery, bariatric surgery, vascularity, perfusion, ICG, laser speckle contrast imaging
- Medical subject headings
- Cholecystitis, Acute, Colorectal Neoplasms, Diverticulitis, Colonic, Obesity, Morbid, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivSightDevice
Use of ActivSight in patients undergoing laparoscopic or robot assisted intestinal anastomoses and patients undergoing laparoscopic or robot assisted cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| ActivSight Group | Experimental | Patients undergoing intestinal anastomoses (colorectal and bariatric) with ActivSight (n=52) Patients undergoing cholecystectomy with ActivSight (n=28) Receives: Device: ActivSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events in 28 days following use of ActivSightTM
To determine safety of ActivSightTM in patients undergoing intestinal anastomoses, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSightTM will be deemed safe if hardware (adaptor or light source)-related major (serious) adverse event is encountered in the treated patients and if less than 2 hardware-related minor adverse events are encountered.
Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to application will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test.
Measured: 28 days
Preparation time of ActivSightTM.
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How easy was ActivSight to set up?
Measured: 1 day
Latency of display of ActivSightTM.
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How specifically did ActivSight display the intended field and the target tissue of interest?
Measured: 1 day
Resolution of display of ActivSightTM.
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How was the display quality of ActivSight on the intended field and target tissue of interest?
Measured: 1 day
Specificity of display of ActivSightTM.
Specificity of display will serve as an outcome for feasibility. Yes/No question for surgeon: "Does the perfusion information displayed by ActivSightTM reflect the expected pattern of blood flow interruption?"
Measured: 1 day
Usability of ActivSightTM by surgeon, as quantified by Likert scale.
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to use while operating."
Measured: 1 day
Support personnel satisfaction with ActivSightTM, as quantified by Likert scale.
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to set up for the procedure."
Measured: 1 day
Secondary outcomes (3)
Ability of ActivSightTM to display perfusion.
ActivSightTM ability to display perfusion at a tissue level during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display tissue perfusion of the anatomy during anastomoses in comparison to ICG?"
Measured: 1 day
Ability of ActivSightTM to display blood vessels.
ActivSightTM ability to display blood vessels during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display vascularity of the anatomy during anastomoses in comparison to ICG?"
Measured: 1 day
Ability of ActivSightTM to display biliary tree.
The clinical metrics for displaying biliary tree will be evaluated using the following question: "Which of the following biliary structures are you able to identify using ActivSightTM with ICG? (Select all that apply): common bile duct (CD), right hepatic duct (RHD), common hepatic duct (CHD), common bile duct (CBD), cystic common bile duct junction (CCBDJ), cystic gallbladder junction (CGJ), accessory ducts (AD)."
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start17 Nov 2020
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Target enrollment is 80 patients. Feasibility will be studied under two categories of operations: feasibility in patients undergoing intestinal anastomoses for bariatric or colorectal surgery (n=52); and feasibility in patients undergoing cholecystectomy (n=28).
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Activ Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center, Houston, University at Buffalo, Ohio State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633512
- Sponsor's protocol ID
- ACF0012020
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2020
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of ActivSightTM Laser Speckle Imaging in Visualization of Tissue Perfusion and Vasculature in Human
- ClinicalTrials.gov ID
- NCT04633512
- Acronym / sponsor ID
- ACF0012020
- Conditions
- Acute Cholecystitis, Colorectal Cancer, Diverticulitis, Colonic, Obesity, Morbid, Inflammatory Bowel Diseases
- Keywords
- laparoscopic, robot assisted surgery, gastrointestinal anastomoses, cholecystectomy, colorectal surgery, bariatric surgery, vascularity, perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Activ SurgicalIndustry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center, Houston, University at Buffalo, Ohio State University
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Design:
- This is a feasibility study designed to evaluate safety and feasibility of ActivSightTM in gastrointestinal anastomoses and cholecystectomy.
- Safety will be determined through clinical assessments and evaluation of any adverse event.
- Feasibility will be determined through technically successful completion of intended visualization.
- Assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to ICG-based visualization and usability.
- Patients outcome and follow up to Postoperative day 28 will be monitored for clinical outcome.
- Target enrollment for the assessment of 80 patients; 52 evaluating intestinal anastomoses cases (including bariatric and colorectal cases); and 28 evaluating laparoscopic cholecystectomy. Stopping rules are triggered following the first 6 patients and a comparison group 6 patients in ICG-based treatment.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Target enrollment is 80 patients. Feasibility will be studied under two categories of operations: feasibility in patients undergoing intestinal anastomoses for bariatric or colorectal surgery (n=52); and feasibility in patients undergoing cholecystectomy (n=28).
| Arm | Type | Receives |
|---|---|---|
| ActivSight Group | Experimental | Device: ActivSightPatients undergoing intestinal anastomoses (colorectal and bariatric) with ActivSight (n=52) Patients undergoing cholecystectomy with ActivSight (n=28) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (4 listed)
- There is no exclusion criteria for ActivSightTM for gastrointestinal resection.
- Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, and pregnancy.
- Patients eligible for cholecystectomy, exclusion criteria include known allergy to iodides; known history of cholangitis, pancreatitis, prior common bile duct injury, coagulopathy or known, preexisting liver disease; pregnancy or breast-feeding; or being of reproductive age with pregnancy possible and not ruled out.
- Patients currently in any investigational agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivSightUse of ActivSight in patients undergoing laparoscopic or robot assisted intestinal anastomoses and patients undergoing laparoscopic or robot assisted cholecystectomy. | Device | ActivSight Group |
Primary outcome
Incidence of Adverse Events in 28 days following use of ActivSightTM
Time frame: 28 days
To determine safety of ActivSightTM in patients undergoing intestinal anastomoses, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSightTM will be deemed safe if hardware (adaptor or light source)-related major (serious) adverse event is encountered in the treated patients and if less than 2 hardware-related minor adverse events are encountered. Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to application will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test.
Preparation time of ActivSightTM.
Time frame: 1 day
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How easy was ActivSight to set up?
Latency of display of ActivSightTM.
Time frame: 1 day
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How specifically did ActivSight display the intended field and the target tissue of interest?
Resolution of display of ActivSightTM.
Time frame: 1 day
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How was the display quality of ActivSight on the intended field and target tissue of interest?
Specificity of display of ActivSightTM.
Time frame: 1 day
Specificity of display will serve as an outcome for feasibility. Yes/No question for surgeon: "Does the perfusion information displayed by ActivSightTM reflect the expected pattern of blood flow interruption?"
Usability of ActivSightTM by surgeon, as quantified by Likert scale.
Time frame: 1 day
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to use while operating."
Support personnel satisfaction with ActivSightTM, as quantified by Likert scale.
Time frame: 1 day
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to set up for the procedure."
3 secondary outcomes
Ability of ActivSightTM to display perfusion.
Time frame: 1 day
Ability of ActivSightTM to display blood vessels.
Time frame: 1 day
Ability of ActivSightTM to display biliary tree.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActivSight in people with Acute Cholecystitis and Colorectal Cancer, run by Activ Surgical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events in 28 days following use of ActivSightTM (time frame: 28 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.