CompletedPhase 2

Tunneled Pleural Catheter in Partially Entrapped Lung

Germany50 participantsStarted 2008-07

Plain-language summary

An open randomized, prospective, single center; parallel group trial to compare efficiency and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with malignant pleural effusion and partial entrapment of the lung.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * One-sided malignant pleural effusion, first occurrence, or following repeated pleuracentesis * History of dyspnea relieved after pleuracentesis * Patient is suitable for VATS * Surgery is indicated by diagnostic necessity * Ability of subject to understand character and individual consequences of clinical trial * Written informed consent must be available before enrolment in the trial * For women with childbearing potential, adequate contraception. * Histological proven pleural carcinosis by immediate sectioning * Intraoperative: partial entrapment of the lung Exclusion Criteria: * Prior lobectomy or pneumonectomy on the affected side * The patient is not operable for general reasons or Karnofsky performance score \< 50 * Intraoperative suspicion of a pleural empyema * Chylothorax * Prior attempts at pleurodesis * Intended or prior intrapleural chemotherapy or radiotherapy * Pregnancy and lactation * Participation in other competing clinical trials and observation period of competing trials

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

global quality scale QL2

Timeframe: 3 months

Trial details

NCT IDNCT00637676

SponsorHeidelberg University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

View on ClinicalTrials.gov More Malignant Pleural Effusion trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.