Clinical trial · Interventional
Validation of ICG to Identify the Urethra During Rectal Surgery
NCT03204201CI-TRIAL-00040018terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Technique failed
Summary
Brief summary (as posted)
This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
| Urethra Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Urethral instillation of ICG
- description
- Urethral instillation of indocyanine green (ICG)
- interventionNames
- Drug: Indocyanine Green Solution
Primary outcomes (1)
- measure
- Number of urethras identified under white light and fluorescence
- timeFrame
- 1 day
Secondary outcomes (4)
- measure
- Signal to background ratios between cohorts of patients with varying doses of ICG
- timeFrame
- 1 day
- measure
- Subjective assessment of usefulness of technology during operative procedure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male, aged 18 years or above. * Undergoing low rectal surgery where the operating field will be close to the urethra Exclusion Criteria: * Participant has an allergy to iodine or ICG * Known liver failure
References
Publications (0)
Data not yet available
No reference posted for this study.