NCT04369118Completed
Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection
Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection. A Multicenter, Prospective, Controlled, Randomized Study With Stratification on the Surgical Approach, Open With a Blind Analysis
Source: ClinicalTrials.gov · Last updated 17 May 2024
Brief summary (registry, in English)
The objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer. The hypothesis is that the use of this medical device would reduce the postoperative pain and increase the efficacy of cough and expectoration. The evolution of the operated patient would be better.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 94 (actual)
- First submitted
- 10 Mar 2020
- Start date
- 18 Nov 2020
- Primary completion date
- 29 Feb 2024
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Lung cancer
- NCT number
- NCT04369118
What you commit to
- Study type: Interventional
- Participants enrolled: 94
- From 18 Nov 2020 to the primary completion date, 29 Feb 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with tuberculosis or other pulmonary infectious pathology proven (aspergillosis, lung abscess, actinomycosis,…),
- Patients with a diagnosed, progressive and/or uncontrolled neurological disease
Other
- Patients with outcomes of the pulmonary function test at the preoperative assessment : forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) \> 45% predicted post-operative values and VO2max (maximal oxygen consumption) between 10 and 12 ml/kg/min,
- Patients with a waist size \> 120 cm
- Patients with medical treatment for chronic pain (neuropathic pain,…)
- Patients carrying a resistant germs or extended-spectrum beta-lactamase (ESBL),
- Paraplegic patients
- Patients with a progressive psychosis or a serious psychotic history (hospitalization)
- Patients who are in exclusion period of another interventional study
- Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Who the study is looking for
- Patients with segmentectomy or lobectomy for lung cancer or lung cancer suspicious,
- Surgical approach : video-assisted thoracic surgery (VATS) or thoracotomy,
- Patients affiliated to social security or similarly regime,
- Patients who gave their consent to participate in the study.
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hôpitaux de Paris, Hôpital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| Hôpital Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| CHU Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.