deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00452426

Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy

Multi-center Pivotal Clinical Trial to Compare the Safety and Effectiveness of Procedural Sedation in GI Endoscopy: A Computer-Assisted Personalized Sedation (CAPS) Device Versus Current Standard of Care

Sponsor: Ethicon Endo-Surgery

Conditions Colonoscopy Conscious Sedation Endoscopy, Digestive System
Interventions Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) benzodiazepines and opioid sedation
Updated 9 times since 2017 Last updated: Dec 30, 2010 Started: Mar 31, 2007 Primary completion: Oct 31, 2007 Completion: Oct 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00452426, this PHASE3 trial focuses on Colonoscopy and Conscious Sedation and remains completed. Sponsored by Ethicon Endo-Surgery, it has been updated 9 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 11 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

▶ Show 4 earlier versions

  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Mar 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ethicon Endo-Surgery
Data source: Ethicon Endo-Surgery

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

Study Locations