SOURCES SOUGHT
B -- Renal Stone Management Technology Development and Clinical Validation Study
- Notice Date
- 7/11/2017
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NASA/Glenn Research Center, 21000 Brookpark Road, Cleveland, Ohio, 44135
- ZIP Code
- 44135
- Solicitation Number
- SHMSI0001
- Archive Date
- 10/2/2017
- Point of Contact
- Melissa A Merrill, Phone: 2164336359
- E-Mail Address
-
melissa.a.merrill@nasa.gov
(melissa.a.merrill@nasa.gov)
- Small Business Set-Aside
- N/A
- Description
- THis RFI is issued solely for Information and Planning purposes and does NOT constitute a solicitation. Responses to this RFI will not be returned. Responders are solely responsible for all expenses associated with any response to this RFI. This synopsis shall NOT be construed as a commitmnet by the Government, nor will the Government pay for the information solicitated. Responders will NOT be notified of any reviews resulting from this RFI. NASA Glenn Research Center (GRC), working in support of NASA's Human Research Program (HRP), seeks to develop mitigating technologies for the risk of renal stone formation, especially among astronaut crew members on long duration missions beyond low-earth orbit. NASA is specifically targeting acoustic and ultrasound-based technologies for stone detection, stone propulsion and stone comminution; however, demonstrably effective non-acoustic methods may also be considered. For this potential solicitation, the Government is seeking a commercial, government or academic entity to validate an existing renal stone management technology (RSMT) for terrestrial use by conducting an up to 3 year clinical study whose primary specific aim is to demonstrate the ability to move ureteral stones and relieve acute renal colic in patients who present with symptoms typical of that condition in a hospital setting. The RSMT system or device shall have the following capabilities: - Stone detection: The RSMT shall detect stones of 2 mm diameter or greater in the kidney, ureter, or lower urinary tract. Stone detection methods that do not use ionizing radiation are strongly preferred. - Stone propulsion: The RSMT shall propel 1-10 mm stones under operator control from one part of the urinary system to another in vivo. Specifically, the system shall support the following desired stone trajectories: 1) dislodge from renal calyx into the ureter, 2) relocate from the ureter back into the kidney, 3) from the ureter into the bladder. - Operating training aids: The RSMT shall include software to provide guidance for trained operators to perform stone detection, stone propulsion and/or stone comminution of an obstructing stone. Training phantoms should also be provided that allow operators to master the required techniques before attempting them in a clinical setting. - Suitability for manned space flight: It is desirable that the RSMT possess (or be capable of being repackaged with) physical characteristics that are compatible with manned space flight. These include, but are not limited to, appropriate physical volume, operational volume, mass, power consumption, and stowage needs when eventually deployed on a manned mission to deep space. The clinical study should include the following: - Specific aim to relieve acute renal colic: The primary measure of the efficacy of the RSMT will be the relief of acute renal colic in hospital patients who are so diagnosed based on the symptoms presented. - Conducted at an institution with a clinical research infrastructure: It is imperative that the institution conducting the study should be well-versed in clinical research protocols and possess the facilities and the means to conduct the study in a hospital care setting. - Institutional Review Board (IRB): The institution conduction the study shall show that both the RSMT system and the study protocol are approved by an appropriately selected IRB. - FDA Research Exemption for the RSMT: The study shall be conducted using either FDA approved devices or devices that have an active FDA research exemption already in place at time of award. - Statistical power analysis: The design of the study shall include a statistical power analysis based on the proposed number of subjects that justifies the power of the study and the level of statistical significance accepted. - Inter-operator variability: The study design shall include an analysis of variability between operators of the RSMT. Outcomes of interest: The outcomes of interest of the study shall be a report or peer-reviewed journal article documenting the study methodology and outcomes and the team's clinical interpretation of the results, and include but not limited to: stone sizes, time to dislodge or relocate, number of study participants, total number of stones imaged, number of stones dislodged and percentage of stones dislodged as a fraction of the number of stones attempted, any adverse effects and feedback on usability and heuristics from the operators. The Government is seeking potential sources for this study. This is a request for information only, this does not guarantee a contract. The Government will not pay for the information provided as a result of this request. The prospective offeror shall provide a not to exceed five page document discussing the following, keeping in mind the capabilities listed above: 1. Business name/potential Offeror and Point of contact, any partnering information and what they provide 2. Contact information - Phone, email, Cage Code 3. RMST system/ device and the capabilities of 4. Clinical study information, may be reference links if the data is accessible It is the offeror's responsibility to monitor this cite for any changes or amendments and for the possible release of a solicitation if any. Ptential offerors will be responsible for downloading their own copy of the solicitation and amendments (if any).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/NASA/GRC/OPDC20220/SHMSI0001/listing.html)
- Place of Performance
- Address: Unknown, United States
- Record
- SN04574771-W 20170713/170711235306-1f152bf5e84ea08cf167c2c3259e194b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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