deltatrials
Completed NA INTERVENTIONAL 2-arm NCT04577456

Chyme Reinfusion for Type 2 Intestinal Failure (REINFUSE)

Pivotal Study to Evaluate the Safety and Efficacy of the Insides™ System in the Treatment of Subjects With a Double Enterostomy and/or Enterocutaneous Fistula and Type 2 Intestinal Failure.

Sponsor: BioValeo

Interventions The Insides System
Updated 14 times since 2020 Last updated: Dec 1, 2025 Started: Oct 15, 2022 Primary completion: Nov 17, 2025 Completion: Nov 18, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04577456, this NA trial focuses on Enterocutaneous Fistula and High Output Stoma and remains completed. Sponsored by BioValeo, it has been updated 14 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~May 2022 · 5 months · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Feb 2023 · 7 months · monthly snapshot~Feb 2023 – ~Sep 2023 · 7 months · monthly snapshot~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jun 2025 · 6 months · monthly snapshot~Jun 2025 – ~Oct 2025 · 4 months · monthly snapshot~Oct 2025 – ~Jan 2026 · 3 months · monthly snapshot~Jan 2026 – present · 6 months · monthly snapshot

Change History

14 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

  2. Oct 2025 — Jan 2026 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  3. Jun 2025 — Oct 2025 [monthly]

    Recruiting NA

  4. Dec 2024 — Jun 2025 [monthly]

    Recruiting NA

  5. Nov 2024 — Dec 2024 [monthly]

    Recruiting NA

Show 9 earlier versions
  1. Sep 2024 — Nov 2024 [monthly]

    Recruiting NA

  2. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  3. Sep 2023 — Jul 2024 [monthly]

    Recruiting NA

  4. Feb 2023 — Sep 2023 [monthly]

    Recruiting NA

    Status: WithheldRecruiting · Phase: NoneNA

  5. Jul 2022 — Feb 2023 [monthly]

    Withheld

  6. May 2022 — Jul 2022 [monthly]

    Withheld

  7. Dec 2021 — May 2022 [monthly]

    Withheld

  8. Jan 2021 — Dec 2021 [monthly]

    Withheld

  9. Nov 2020 — Jan 2021 [monthly]

    Withheld

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • BioValeo
  • Databean
  • Green Lane Coordinating Centre Limited
  • The Insides Company
Data source: The Insides Company

For direct contact, visit the study record on ClinicalTrials.gov .