Intraoperative identification of the ureters is improved with ZW800-1 and fluorescence imaging
ID
Bron
Verkorte titel
Aandoening
Lower abdominal and pelvic laparoscopic surgeries
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To assess the feasibility of ZW800-1 in intraoperative detection of the urinary tract using the NIR fluorescence imaging system.
Achtergrond van het onderzoek
Iatrogenic ureteral injury during abdominal surgery is a rare but serious complication with incidences varying from 0.7% to 10%. ZW800-1 is a novel fluorophore and in pre-clinical studies it has proven to be a valid agent for molecular imaging, due to low non-specific binding and uptake, and an exclusive renal clearance. More importantly, ZW800-1 has been proven safe. A phase 1 study has been conducted in healthy volunteers and based on the results we believe ZW800-1 is an ideal candidate to visualize the urinary tract during surgery to prevent iatrogenic ureteral damage.
Doel van het onderzoek
Intraoperative identification of the ureters is improved with ZW800-1 and fluorescence imaging
Onderzoeksopzet
-
Onderzoeksproduct en/of interventie
Injection ZW800-1 and fluorescence imaging during surgery
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1) Patients >18 years old;
2) Patients scheduled and eligible for laparoscopic surgery in the lower abdominal or pelvic area;
3) Patients should be capable and willing to give informed consent before study specific procedures;
4) No unacceptable known cardiovascular or pulmonary disease, renal or liver dysfunction;
5) The screening ECG and laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant;
6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients will be excluded if any of the criteria below apply:
1) History of a clinically significant allergy or anaphylaxis;
2) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
3) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7209 |
| NTR-old | NTR7408 |
| Ander register | METC LUMC : P17.125 |