4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) (VACStent)

Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) (VACStent)

Study Description
Brief Summary:

Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.

Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract


Condition or disease Intervention/treatment Phase
Perforation Esophagus Esophageal Cancer Esophageal Achalasia Esophageal Diseases Device: VACStent Not Applicable

Detailed Description:
The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
Actual Study Start Date : September 22, 2019
Actual Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: VACStent Group
Patient s who received a VACStent
 Device: VACStent
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
Outcome Measures
Primary Outcome Measures :
  1. Technique - % of patients with successful implantation of VACStent [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with successful implantation of VACStent


Secondary Outcome Measures :
  1. Healing of leak - % of patients with successful implantation of VACStent [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with a sealed leak after successful treatment with VACStent

  2. Treatment of sepsis [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with successful treatment of sepsis leak after successful implantation of VACStent

  3. Migration rate [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with migration of VACStent after successful implantation of VACStent

  4. Bleeding [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with bleeding after successful implantation of VACStent

  5. Arrosion of tissue structures [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent

  6. Sealing of leak - % of patients with successful implantation of VACStent [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with a sealed leak after successful treatment with VACStent


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination
  • Accessibility of the leak with the delivery system of the VAC stent

Exclusion Criteria:

  • Simultaneous participation in other interventional exams
  • Endoscopic inaccessibility of the affected section
  • Full anticoagulation with international normalized ratio (INR) > 1.5 and / or partial thromboplastin time (PTT) > 50 sec, or platelets <20.000 / μl (after therapeutic correction an inclusion is possible)
  • Unstable patients with severe septic disease, who have a clinical history
  • Assessment an immediate operation for safe focus switch-off requires
  • Ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible)
  • Persons who are in a dependency / employment relationship with the sponsor or examiner stand
  • Accommodation in an institution for judicial or regulatory purposes arrangement
Contacts and Locations

Locations
Layout table for location information
Germany
University Hospital of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University Hospital of Cologne
Investigators
Layout table for investigator information
Principal Investigator: Seung-Hun Chon, M.D. University Hospital of Cologne
Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE September 22, 2019
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2019) 		Technique - % of patients with successful implantation of VACStent [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
% of patients with successful implantation of VACStent
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Technique - % of patients with successful implantation of VACStent [ Time Frame: 1 year ]
% of patients with successful implantation of VACStent
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • Healing of leak - % of patients with successful implantation of VACStent [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with a sealed leak after successful treatment with VACStent
  • Treatment of sepsis [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with successful treatment of sepsis leak after successful implantation of VACStent
  • Migration rate [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with migration of VACStent after successful implantation of VACStent
  • Bleeding [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with bleeding after successful implantation of VACStent
  • Arrosion of tissue structures [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent
  • Sealing of leak - % of patients with successful implantation of VACStent [ Time Frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months ]
    % of patients with a sealed leak after successful treatment with VACStent
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
Official Title  ICMJE VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
Brief Summary

Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.

Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
Detailed Description The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Perforation Esophagus
  • Esophageal Cancer
  • Esophageal Achalasia
  • Esophageal Diseases
Intervention  ICMJE Device: VACStent
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
Study Arms  ICMJE Experimental: VACStent Group
Patient s who received a VACStent
Intervention: Device: VACStent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 15, 2020) 		20
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		15
Estimated Study Completion Date  ICMJE November 30, 2021
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination
  • Accessibility of the leak with the delivery system of the VAC stent

Exclusion Criteria:

  • Simultaneous participation in other interventional exams
  • Endoscopic inaccessibility of the affected section
  • Full anticoagulation with international normalized ratio (INR) > 1.5 and / or partial thromboplastin time (PTT) > 50 sec, or platelets <20.000 / μl (after therapeutic correction an inclusion is possible)
  • Unstable patients with severe septic disease, who have a clinical history
  • Assessment an immediate operation for safe focus switch-off requires
  • Ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible)
  • Persons who are in a dependency / employment relationship with the sponsor or examiner stand
  • Accommodation in an institution for judicial or regulatory purposes arrangement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962179
Other Study ID Numbers  ICMJE 19-1053_1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seung-Hun Chon, University Hospital of Cologne
Study Sponsor  ICMJE University Hospital of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seung-Hun Chon, M.D. University Hospital of Cologne
PRS Account University Hospital of Cologne
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯