Healthy Volunteers Clinical Trial
— LEGENDOfficial title:
Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study
NCT number | NCT03520582 |
Other study ID # | 16.22.CLI |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 6, 2017 |
Est. completion date | July 30, 2018 |
Verified date | September 2018 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube.
Status | Terminated |
Enrollment | 12 |
Est. completion date | July 30, 2018 |
Est. primary completion date | June 7, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Healthy volunteers - Informed Consent as documented by signature (Appendix Informed Consent Form) - Age >18 years Patients - Age >18 years - mechanically ventilated and requiring a placement of a postpyloric feeding tube on clinical indications - Informed Consent as documented by signature of relatives Exclusion Criteria: Healthy volunteers and patients - Unrepaired tracheoesophageal fistula - history of prior esophageal or gastric surgery - esophageal obstruction, stricture, varices or diverticulum - esophageal or gastric perforation, gastric or esophageal bleeding - recent oropharyngeal surgery - cervical spine injury or anomaly Additional exclusion criterion for patients only • know severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or International Normalized Ratio (INR) > 3) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsklinik für Intensivmedizin | Bern |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | |
Secondary | In healthy volunteers, time required to reach gastric and postpyloric placement | Questionnaire with various positions and the time to reach the position | During Intervention Visit, an average of 24 hours | |
Secondary | In healthy volunteers, ease of insertion, handling, and image quality assessed | Using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | |
Secondary | In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction | Using a visual analog scale of 1-10, with 1 indicating the best value. | During Intervention Visit, an average of 24 hours | |
Secondary | In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation. | Questionnaire Yes/No and a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | |
Secondary | In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | |
Secondary | In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | |
Secondary | In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | |
Secondary | In patients: Time required to reach gastric and postpyloric placement | Questionnaire | During Intervention Visit, an average of 24 hours | |
Secondary | In patients: Feasibility of the feeding through Veritract tube. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | |
Secondary | Bleeding and infection related to tube placement | AE/SAE Questionnaire Yes/No | During Intervention Visit, an average of 24 hours | |
Secondary | Erroneous placement in larynx and trachea and associated complications (pneumothorax). | Outcome mesured with a questionnaire Yes/No | During Intervention Visit, an average of 24 hours | |
Secondary | Injuries of the oesophagus, stomach or small intestine related to tube placement. | Outcome mesured with a questionnaire Yes/No | During Intervention Visit, an average of 24 hours | |
Secondary | Reflux of stomach contents during tube placement | AE/SAE Questionnaire Yes/No | During Intervention Visit, an average of 24 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |