NCT07800325

Brief Summary

Evaluation of the efficacy and safety of the Rengine extracorporeal cardiopulmonary support system and the ECMO sterile oxygenator in the management of respiratory failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 29, 2026

Last Update Submit

August 29, 2026

Conditions

Respiration Failure

Outcome Measures

Primary Outcomes (1)

  • survival

    Day 7 post-treatment

Study Arms (1)

ECMO

EXPERIMENTAL

Using ECMO in the management of respiratory failure

Other: ECMO

Interventions

ECMOOTHER

Using ECMO in the management of respiratory failure

ECMO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18, male or female;
  • Patients with respiratory failure and high Paco2, PH \< 7.35；
  • Researchers believe that this product is beneficial for patients undergoing treatment, such as patients with invasive ventilator weaning difficulty, large airway obstruction, etc；
  • Patients or guardians provided written informed consent voluntarily.

You may not qualify if:

  • Oxygenation index \<80mmHg;
  • Intracranial hemorrhage or severe irreversible brain injury;
  • Thrombocytopenia;
  • Patients with malignant tumors (expected survival time \<1 year);
  • patients unable to receive systemic anticoagulation;
  • Obesity: BMI\>40kg/m2;
  • Those with a history of mental illness who were unable to cooperate in completing the trial;
  • During pregnancy and lactation;
  • Patients with allergic or severe allergic constitution to the test equipment;
  • Participated in other interventional device clinical trials within 3 months before this trial
  • Those who were deemed unsuitable to participate in the trial by the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 102300, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2026

First Posted

September 2, 2026

Study Start

December 1, 2024

Primary Completion

April 4, 2026

Study Completion

April 4, 2026

Last Updated

September 2, 2026

Record last verified: 2026-08

Locations

CN(1)