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NCT04253028
Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.
EARLY_PHASE1 trial testing NERv's Inline Device in Anastomotic Leak in 9 participants. Completed in 15 March 2020.
15 March 2020
Quick facts
| Lead sponsor | FluidAI Medical |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 9 |
| Start date | 29 January 2020 |
| Primary completion | 15 March 2020 |
| Estimated completion | 15 March 2020 |
| Sites | 2 locations across Egypt |
Drugs / interventions tested
- NERv's Inline Device
Conditions studied
- Anastomotic Leak — all drugs for Anastomotic Leak →
Sponsor
FluidAI Medical
Who can join
18 and older, any sex, with Anastomotic Leak. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical post-operative anastomotic/intraperitoneal leakages. NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains. The purpose of NERv's feasibility clinical trial is to collect pH and conductance readings by analyzing peritoneal drainage fluid. Upon analyzing data collected from NERv's Inline Device a clinical model of pH and conductance will be created. The clinical model can then be used to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established where if the signal goes outside the boundaries a complication could be identified. Specifically the ability to detect a post-operative complication known as anastomotic leakage; which is a dreaded complication associated with abdominal surgeries; will be the main focus of the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04253028
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NERv's Inline Device
Trials testing the same drug.
- NCT04582708 — Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications · Phase 2 · completed
Other recruiting trials for Anastomotic Leak
Currently open trials in the same condition.
- NCT07449208 — Registry Study of People Who Are Having an Esophagectomy and Are at High Risk of Anastomotic Leak · recruiting
- NCT07351071 — Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Res · NA · recruiting
- NCT07144683 — Anastomotic Leakage After Colorectal Surgery. · recruiting
- NCT07036588 — PARLAR-02 Trial：Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage · NA · recruiting
- NCT06553261 — Anastomotic Leakage in Right Colectomy · recruiting
Other FluidAI Medical trials
Trials by the same sponsor.
- NCT06522061 — Evaluating the Effective and Safe Use of Stream™ Platform · NA · not yet recruiting
- NCT04582708 — Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications · Phase 2 · completed
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 NCT04253028 (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 FluidAI Medical
- Last refreshed: 12 August 2020
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/NCT04253028.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing