5 completed, 4 unknown, 2 not yet recruiting, 1 recruiting. 5 Not applicable, 2 Phase 1, 2 Phase 2, 1 Early Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 5 | Unknown 4, Recruiting 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Completed 2 |
| Early Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Not yet recruiting 1 |
| Phase 4 | 1 | Completed 1 |
Follow Indigo Carmine: new trials by email Literature Review of Indigo Carmine trials Research Report on Indigo Carmine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients Indigotindisulfonate sodium 0.8% injection - Ureter Injury | Phase 3 | Not yet recruiting | Prove pharm | 18 | 2026-12-01 | 2026-10-16 |
| Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL) Chromoendoscopy (Indigo Carmine), Virtual Chromoendoscopy - Familial Adenomatous Polyposis (FAP), Pouches, Ileoanal | Not applicable | Recruiting | London North West Healthcare NHS Trust | 50 | 2026-07-09 | 2026-07-24 |
| Hemodynamic and Respiratory Instability During Percutaneous Pulmonary Thrombectomy Percutaneous Pulmonary Thrombectomy (FlowTriever), Percutaneous Pulmonary Thrombectomy (Indigo) - Pulmonary Embolism Acute | Not yet recruiting | Hospital Universitari Vall d'Hebron Research Institute | 100 | 2026-04-10 | 2026-05-04 | |
| Chromoendoscopy in Inflammatory Bowel Disease indigo-carmine 0.2% using a spray catheter, 0.03% using a foot pump - Colonoscopy | Not applicable | Unknown | The Leeds Teaching Hospitals NHS Trust | 300 | 2017-01-01 | 2019-06-18 |
| Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease Methylene Blue, FD&C Blue # 2, Phenazopyridine hydrochloride - Mild Cognitive Impairment, MCI | Phase 2 | Completed | The University of Texas Health Science Center at San Antonio | 117 | 2015-07-01 | 2024-09-19 |
| Effects of USP Methylene Blue on Cognitive and fMRI Brain Activity Methylene Blue (USP grade, 280mg oral), Placebo - Brain Activity | Early Phase 1 | Completed | The University of Texas Health Science Center at San Antonio | 36 | 2013-08-01 | 2017-04-11 |
| Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine Indigo Carmine - Inflammatory Bowel Diseases | Not applicable | Unknown | Hillel Yaffe Medical Center | 10 | 2013-08-01 | 2013-08-02 |
| Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT) Indigo carmine, water (exchange) method, water (exchange) plus dye method - Colorectal Neoplasms | Phase 4 | Completed | VA Office of Research and Development | 480 | 2013-05-16 | 2019-01-15 |
| Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep Chromoendoscopy (Indigo Carmine), Control - Colonic Polyps | Phase 1 | Completed | Mayo Clinic | 21 | 2013-05-01 | 2015-03-03 |
| Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection Indigo carmine - Brain Tumors With Ill-defined Margins | Phase 1 / Phase 2 | Completed | Weill Medical College of Cornell University | 10 | 2012-04-01 | 2018-12-11 |
| Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease Colonoscopy with Indigo-Carmine chromoendoscopy, Conventional white-light colonoscopy - Ulcerative Colitis, Crohn's Colitis | Not applicable | Unknown | Karolinska University Hospital | 304 | 2011-02-01 | 2019-03-06 |
| Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis Colonoscopy with Indigo-Carmine Chromoendoscopy - Chronic Diarrhoea, Lymphocytic Colitis | Not applicable | Unknown | Karolinska University Hospital | 150 | 2009-06-01 | 2015-08-06 |
Inflammatory Bowel Diseases (3) · Adenomatous Polyposis Coli (1) · Alzheimer Disease (1) · Brain Neoplasms (1) · Cognitive Dysfunction (1) · Colitis, Collagenous (1) · Colitis, Lymphocytic (1) · Colitis, Microscopic (1) · Colitis, Ulcerative (1) · Colonic Polyps (1) · Colorectal Neoplasms (1) · Crohn Disease (1) · Intestinal Diseases (1) · Mental Fatigue (1) · Neoplasms (1)
Karolinska University Hospital (2) · The University of Texas Health Science Center at San Antonio (2) · Hillel Yaffe Medical Center (1) · Hospital Universitari Vall d'Hebron Research Institute (1) · London North West Healthcare NHS Trust (1) · Mayo Clinic (1) · Prove pharm (1) · The Leeds Teaching Hospitals NHS Trust (1) · VA Office of Research and Development (1) · Weill Medical College of Cornell University (1)
United States (5) · Sweden (2) · United Kingdom (2) · Israel (1) · Spain (1)
Peter T Schmidt, MD, PhD (2) · Andre Latchford, MBBS PhD FRCP (1) · Joseph W. Leung, MD (1) · Lisa Schwartz (1) · M Harrison, MD (1) · Theodore Schwartz, MD (1) · Timothy Q. Duong, Ph.D. (1) · Vitaly Verzhbitsky, MD (1)