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NCT06608082: HYSTINDO
Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection.
NA trial testing indocyanine green injected intravenously in Hysterectomy in 90 participants. Currently enrolling.
31 March 2025
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 90 |
| Start date | 21 September 2024 |
| Primary completion | 31 March 2025 |
| Estimated completion | 30 November 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- indocyanine green injected intravenously
Conditions studied
- Hysterectomy — all drugs for Hysterectomy →
- Vascularization — all drugs for Vascularization →
- Complication of Surgical Procedure — all drugs for Complication of Surgical Procedure →
Sponsor
University Hospital, Clermont-Ferrand
Who can join
18 and older, female only, with Hysterectomy or Vascularization. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hysterectomy is one of the most common surgical procedures in gynecology, especially by laparoscopy. Post-operative complications of hysterectomy are numerous and their causes are poorly understood. Indocyanine green is a fluorescent dye that, when exposed to infrared light, makes it possible to visualize the vascularization by fluorescence. The project consists in studying the vascularization of the vaginal cuff after total laparoscopic hysterectomy using the injection of indocyanine green. This is a prospective feasibility study. During the procedure, after performing the hysterectomy, indocyanine green will be injected intravenously into the patient. A fluorescence video of the vaginal cuff will be recorded. The fluorescence of the recorded images will be analyzed by fluorescence analysis software to obtain an objective value of fluorescence. The fluorescence values will be compared to the occurrence or absence of postoperative complications. This is the first study using this imaging technique combined with indocyanine green in this surgery. This study will employ a novel objective sequential fluorescence analysis software that has already proven its effectiveness in digestive surgery. The sequential measurement of the change in fluorescence intensity visualized in the images of laparoscopy will enable the production of vaginal perfusion graphs using a video modeling tool such as the TRACKER software. This software measures the evolution of green levels in a region of interest, from which a time-fluorescence curve can be obtained. The presence of fluorescence will be defined by a fluorescence intensity value of Fmax-Fmin on the graph.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06608082
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06608082 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Clermont-Ferrand
- Last refreshed: 23 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06608082.
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