Safety and Feasibility of ActivSightTM in Human : Safety and Feasibility of ActivSightTM Laser Speckle Imaging in Visualization of Tissue Perfusion and Vasculature in Human
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..
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 21. Feb. Zur Gesamtaufnahme - year:2024 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: November 18, 2020, Last downloaded: ClinicalTrials.gov processed this data on February 28, 2024, Last updated: February 28, 2024 |
|---|
| Study ID: |
NCT04633512 |
|---|---|
| Veröffentlichungen zur Studie: |
|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG003580113 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG003580113 | ||
| 003 | DE-627 | ||
| 005 | 20240228010426.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 210408s2024 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG003580113 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT04633512 | ||
| 035 | |a (UBBS_Klinische_Studien)ACF0012020 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a Safety and Feasibility of ActivSightTM in Human |b Safety and Feasibility of ActivSightTM Laser Speckle Imaging in Visualization of Tissue Perfusion and Vasculature in Human |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: November 18, 2020, Last downloaded: ClinicalTrials.gov processed this data on February 28, 2024, Last updated: February 28, 2024 | ||
| 520 | |a 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. | ||
| 650 | 2 | |a Inflammatory Bowel Diseases | |
| 650 | 2 | |a Cholecystitis | |
| 650 | 2 | |a Diverticulitis | |
| 650 | 2 | |a Cholecystitis, Acute | |
| 650 | 2 | |a Diverticulitis, Colonic | |
| 650 | 2 | |a Obesity, Morbid | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Enrolling by invitation | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 21. Feb. |
| 773 | 1 | 8 | |g year:2024 |g day:21 |g month:02 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT04633512 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 21 |c 02 | ||