NCT04978090 is a NA clinical trial of 3D printed EAF management device in Fistula, sponsored by Andrew Bernard.

Who is sponsoring NCT04978090?

NCT04978090 is sponsored by Andrew Bernard.

What drugs are being tested in NCT04978090?

Interventions in NCT04978090: 3D printed EAF management device.

What condition does NCT04978090 study?

NCT04978090 studies Fistula, Abdominal Injury, Negative Pressure Wound Therapy.

Is NCT04978090 still recruiting?

NCT04978090 is currently completed. Last updated 10 October 2023.

Are results published for NCT04978090?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-10 · How we verify

NCT04978090

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy

Completed NA Results posted Last updated 10 October 2023

What this trial tests

NA trial testing 3D printed EAF management device in Fistula in 2 participants. Completed in 16 September 2022.

Timeline

1 July 2021

Primary endpoint
16 September 2022

16 September 2022

Quick facts

Lead sponsor	Andrew Bernard
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	2
Start date	1 July 2021
Primary completion	16 September 2022
Estimated completion	16 September 2022
Sites	1 location across United States

Drugs / interventions tested

3D printed EAF management device

Conditions studied

Fistula — all drugs for Fistula →
Abdominal Injury — all drugs for Abdominal Injury →
Negative Pressure Wound Therapy — all drugs for Negative Pressure Wound Therapy →

Sponsor

Andrew Bernard

Who can join

18 and older, any sex, with Fistula or Abdominal Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing changes, time required for dressing changes, management costs, and the ease of use.

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:

Other recruiting trials for Fistula

Currently open trials in the same condition.

NCT05444504 — Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management · NA · recruiting
NCT04940611 — A Study of Surgical Interventions in Fistulizing Conditions · active not recruiting

Other Andrew Bernard trials

Trials by the same sponsor.

NCT07227090 — 2025 Mental Health Education Tool · NA · completed
NCT07227181 — 2025 Animal Assisted Therapy · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04978090 (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 Andrew Bernard
Last refreshed: 10 October 2023

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/NCT04978090.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing