deltatrials
Terminated PHASE3 INTERVENTIONAL 1-arm NCT03335059

Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors. (RITE-USA)

A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect (RITE) With Mitomycin C (Synergo® RITE + MMC) in CIS Non-Muscle Invasive Bladder Cancer (NMIBC) Bacillus Calmette-Guérin (BCG)-Unresponsive Patients With or Without Papillary NMIBC

Sponsor: Medical Enterprises Ltd.

Conditions BCG-Unresponsive Bladder Cancer Bladder Cancer Bladder Neoplasm Bladder Tumors Cancer of Bladder Cancer of the Bladder Carcinoma in Situ of Bladder Malignant Tumor of Urinary Bladder Neoplasms, Bladder Papillary Carcinoma of Bladder (Diagnosis) Urinary Bladder Cancer
Interventions Synergo® RITE + MMC
Updated 14 times since 2017 Last updated: Apr 14, 2020 Started: Apr 4, 2019 Primary completion: Feb 26, 2020 Completion: Feb 26, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

poor enrollment

A PHASE3 clinical study on BCG-Unresponsive Bladder Cancer and Bladder Cancer, this trial is terminated or withdrawn. The trial is conducted by Medical Enterprises Ltd. and has accumulated 14 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Feb 2019 · 7 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Apr 2020 · 9 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

14 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  4. May 2020 — Jan 2021 [monthly]

    Terminated PHASE3

    Status: Recruiting → Terminated

  5. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

▶ Show 9 earlier versions

  1. Jul 2019 — Apr 2020 [monthly]

    Recruiting PHASE3

  2. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  3. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  4. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  5. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  6. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  7. Jul 2018 — Feb 2019 [monthly]

    Not Yet Recruiting PHASE3

  8. Jun 2018 — Jul 2018 [monthly]

    Not Yet Recruiting PHASE3

  9. Dec 2017 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Medical Enterprises Ltd.
Data source: Medical Enterprises Ltd.

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

Study Locations