Figures cited from the live ClinicalTrials.gov record NCT05732818 (first posted 17 February 2023; last update posted 9 November 2026), verified 9 November 2026. General information, not legal or regulatory advice. Confirm current DINAVISA and FDA rules with qualified advisers. We name only the hospital and trial that source supports. Spinal Stabilization Technologies is not claimed as a bioaccess® client.
If you searched Sanatorio Americano Asunción clinical trial, Sanatorio Americano first-in-human, PerQdisc Paraguay, LOPAIN3, or “go direct to the site in Asunción,” you followed a facility string ClinicalTrials.gov published and updated on 9 November 2026. Sanatorio Americano in Asunción, Paraguay, is a real named hospital. It is not the operator of the DINAVISA file.
bioaccess®’s position is simple and it is not adversarial: Sanatorio Americano is the site. The First-in-Human CRO still owns DINAVISA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia, Panama, or another Latin American country if one Asunción hospital is not enough. That last point matters here more than usual, because the public record says this study stalled on enrollment.
This page is the intercept for that search. It does not clone CRO in Paraguay or Clinical trials in Paraguay; those stay the country operating system. The other Asunción hospital intercept stays on its own building: Hospital Italiano Asunción. This page answers the Sanatorio Americano facility query.
Why the hospital name wins the search — and why that is not a CRO
NCT05732818 is an industry device listing. Brief title: Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3. Official title: Clinical Investigation Plan First in Human Trial Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy “LOPAIN3”. Lead sponsor: Spinal Stabilization Technologies, class INDUSTRY. One collaborator is listed, Raylytic GmbH (class INDUSTRY). The record does not describe any organization as a CRO.
Registry dates retrieved 9 November 2026: first submitted 30 January 2023; first posted 17 February 2023; actual start 16 June 2023; last update submitted 4 November 2026; last update posted 9 November 2026. Estimated enrollment 50. Single-group, open-label, phase N/A, primary purpose treatment, with a data monitoring committee. Two location rows: Sanatorio Americano, Asunción, Paraguay, and a specialized medical center in Tashkent, Uzbekistan. No principal investigator is named on the record.
The device, in the registry’s words, is the PerQdisc® Nucleus Replacement System, a lumbar disc nucleus replacement implanted right after a successful discectomy through a minimally invasive posterolateral approach, in adults 21 or older with radiculopathy from a focal lumbar disc herniation. The primary outcome is freedom from serious adverse events definitely related to the device or procedure at 12 months; secondary outcomes track Oswestry Disability Index and back-pain VAS out to 24 months. That is a first-in-human safety-and-performance frame, not a pivotal trial.
The part sponsors should read twice: status SUSPENDED
On the 9 November 2026 update, overall status is SUSPENDED. The reason the sponsor entered, verbatim: “The study was suspended as enrollment of patients was difficult and no participants could be found for two years.” Estimated primary completion is now September 2027.
That is the most useful sentence on the record for anyone googling this hospital. A named site and a registered first-in-human protocol did not, on their own, produce patients. Recruitment in a first-in-human device study is a system: referral networks, pre-screening, imaging review, a Medical Advisory Board cadence that keeps up, and the option to open another country when one building runs dry. That is CRO work. We say this without criticizing the hospital; the record does not say why enrollment failed, and we will not guess.
Sanatorio Americano is a site. The CRO is the operator.
What a site can typically do when a sponsor “goes direct”:
- Discuss investigator interest and surgical feasibility for a spine protocol — when that service is available and appropriate for your device, which is not automatic.
- Share institutional ethics-committee calendars and hospital research rules.
- Quote procedure, bed, and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- DINAVISA. Paraguay’s national sanitary authority (Dirección Nacional de Vigilancia Sanitaria) is the file a sponsor actually needs for an investigational device. See DINAVISA trial authorization vs. registro.
- Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent an Asunción-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review when the study meets that rule’s GCP and ethics documentation. Eligibility is not clearance. The record lists the study as not an FDA-regulated device; that does not make a later U.S. file automatic.
- Recruitment rescue and multi-country optionality. If one hospital cannot find patients, a single-hospital MSA will not open Colombia or Panama for you.
Site versus CRO
| Workstream | What Sanatorio Americano (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Operating room, imaging, spine surgeons, local staff | Protocol fit, training, implant accountability |
| Ethics | Institutional committee calendar | Packet, ICF, IB, committee coordination |
| National authority | Not the permit holder by being listed on an NCT | DINAVISA authorization and investigational import |
| Recruitment | Its own patient flow | Referral strategy, pre-screening, added sites or countries |
| Quality | Hospital quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance |
What the public file supports — and what it does not
- Device: PerQdisc® Nucleus Replacement System, lumbar disc nucleus replacement after discectomy.
- Sponsor: Spinal Stabilization Technologies (industry). Collaborator Raylytic GmbH (industry). No organization described as a CRO.
- Sites: Sanatorio Americano, Asunción, Paraguay; one site in Tashkent, Uzbekistan.
- Design: first-in-human, single-group, estimated n=50; started June 2023; suspended for enrollment difficulty on the 9 November 2026 update.
- Not claimed here: that the NCT named bioaccess®; that Spinal Stabilization Technologies is a bioaccess® client; that we know how many patients, if any, were treated in Asunción; that we have outcomes; that Sanatorio Americano is the same building as Hospital Italiano Asunción.
Colombia is still on the map
bioaccess® still runs clinical trials in Colombia, alongside Paraguay, Panama, and the rest of the platform. bioaccess® was founded in 2010 and coordinates first-in-human and early-feasibility device studies with a U.S. sponsor desk. That is the operator layer around a named Asunción site. We will not rewrite NCT05732818 as a bioaccess® study.
Frequently asked questions
Can I contract Sanatorio Americano directly?
You can try. The hospital can discuss investigator interest, local procedure costs, and ethics calendars. It cannot, by being named on NCT05732818, become your DINAVISA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager.
Is this a first-in-human study?
Yes, by its own official title: “First in Human Trial … LOPAIN3.” It is currently suspended, per the sponsor’s entry, because no participants could be found for two years.
Who is the principal investigator?
The record does not name one, so neither do we.
Did bioaccess® run this study?
No public bioaccess® page says so, and the record names no CRO. We will not invent that claim.
What does the CRO do that a stalled single-site study is missing?
Country and site choice built around where the patients actually are; the DINAVISA packet; insurance; investigational import; activation; ISO 14155 monitoring; the 21 CFR 812.28 narrative; and the option to add Colombia or Panama when one building cannot enroll.
Next step
If the search that brought you here was Sanatorio Americano, PerQdisc, or LOPAIN3, start with the operator: contact bioaccess® or see First-in-Human CRO. Hub: ClinicalTrials.gov FIH sites vs the CRO. Country: CRO in Paraguay, CRO in Colombia, Panama.