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临床试验/NCT07745088
NCT07745088已完成不适用

Impact on Patients With Neuromuscular and Musculoskeletal Conditions Associated With Benign Chronic Pain Using Atlas Profilapxis

Fundacion Nacional Somos1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
pain reduction

研究概览

简要总结

AtlasPROfilax®is a method performed in 2 authorized centers in Colombia focused on patients with chronic non-malignant pain. The study seeks to see the effectiveness of the method in different pathologies through a randomized double-blind study.

详细描述

The SUPRANAV project, focused on the development, clinical validation and technological evolution of the SUPRAtube medical device, responds to a critical need in the management of mechanically ventilated patients: the optimization of the cleanliness, functionality and safety of the orotracheal tube through an original technological solution, designed in Colombia. This device was evaluated in the framework of a randomized clinical trial, duly registered and published in an indexed scientific journal after peer review, demonstrating its innovative nature and clinical added value. During its initial phases, the project received public funding from MINCIENCIAS, which allowed it to complete its validation in a real clinical environment and reach advanced levels of technological maturity. However, the transition from invention to widespread use in national clinical practice requires a number of highly specialized and expensive activities that were not covered by the original funding.

Progress and Activities Executed in 2024 (With Own Resources) During 2024, the SUPRAtube development team, led from Santander, has assumed an exemplary institutional commitment by continuing with the project despite the absence of direct public funding, executing essential tasks for its effective implementation in the health system: Iterative redesign of the device based on post-trial clinical feedback. 3D printing of new prototypes for functional and usability testing. Optimization of industrial molds for future manufacturing at scale. Technical and regulatory documentation for the sanitary registration with INVIMA. Technological packaging and standardization of components. Adjustments of production plant and technical infrastructure. Testing of quality control, safety and consistency of the final product. These actions, financed with own resources, have required significant investments of time, talent and capital, evidencing a strong ethical, scientific and social commitment on the part of the executing entities. Without them, the real impact of innovation in the national clinical environment would not be possible.

Sectoral and Regional Impact The development and consolidation of the SUPRAtube have been carried out in the department of Santander, which positions the region as a national benchmark in biomedical innovation and technological production in health. The project successfully articulates: Highly complex clinical institutions, research and technological development centers, and specialized industrial companies, creating a regional innovation ecosystem aligned with the public policies of: Reindustrialization of the PND 2022-2026, Health Sovereignty, and The Health Mission of the PIIOM (Mission-Oriented Research and Innovation Policy). A tangible impact is expected on: The quality of care for critical patients, the generation of qualified employment, the transfer of knowledge, and the strengthening of the local business fabric, with national projection. Justification for the Application for Tax Benefits The SUPRANAV / SUPRAtube project fully complies with the technical and strategic requirements established by MINCIENCIAS to access tax benefits in R+D+i activities: It is led by accredited entities, with a proven track record. It involves qualified scientific and technical personnel, with registered remuneration. It aligns with national priorities in health, technology, and productive sovereignty. It was co-financed by MINCIENCIAS during its initial stages (Liquidation Act - August 2024). It presents verifiable results with commercial potential and healthcare impact. It has involved its own institutional investments in key activities not covered by initial public funding. Therefore, this application is not only eligible, but also strategic and necessary, as it brings innovation closer to the end patient and closes the critical gap between invention and real access to the medical device in safe, regulated and scalable conditions. Pending Phases and Projected Improvements To consolidate the impact and ensure sustainability, additional phases have been identified that require support and eventually new investments: Good Manufacturing Practices (GMP) certification. Complementary post-marketing trials. Strategy for adoption and transfer in hospital network. Industrial scaling and strategic licensing. Strategies for technological surveillance and updating of the device. Internationalization and additional protection of intellectual property. These stages will allow the SUPRAtube device not only to benefit the Colombian health system, but also to be projected as an exportable success story of biomedical innovation from regions of Colombia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over the age of 18
  • patient who consult the authorized Atlas care center
  • patients with chronic non-malignant pain.

排除标准

  • Inability to perform physical therapies.
  • patient with pain neuropatict indiferent

结局指标

主要结局

pain reduction

时间窗: Baseline day 1, post treatment at 1 month post treatment , at 3 months post treatment , at 6 months post treatment, and at 12 months after the start of the intervention.

Description: The patient is asked to rate their pain on a scale of 1 to 10. Scoring: 0: No pain. 1-3: Mild or slight pain. 4-6: Moderate pain. 7-10: Severe pain, the worst pain imaginable. Measurement will be taken on day 1, at 1 month, at 3 months, at 6 months, and at 12 months after the start of the intervention.

次要结局

  • fatigue severity scale(Baseline day 1, post treatment at 1 month post treatment , at 3 months post treatment , at 6 months post treatment, and at 12 months after the start of the intervention)

研究者

发起方
Fundacion Nacional Somos
申办方类型
Other
责任方
Sponsor

研究点 (1)

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