Protocol of a prospective sequential observational study using a novel rapid parathyroid hormone detection-tool to be used during parathyroid surgeries compared to the standard procedure.

Protocol of a prospective sequential observational study using a novel rapid parathyroid hormone detection-tool to be used during parathyroid surgeries compared to the standard procedure. - SIMPRO-IO-I-PTH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011066

Enrollment

Registered

2016-10-14

Start date

2017-02-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E21

Interventions

Group 1: standard method ECLIA: immunological in vitro assay for quantitative determination of parathormone in human serum and plasma Group 2: new method IO-I-PTH: immunological in vitro assay for qua

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. benign parathyroid diseases with indication for elective resection 2. the patient’s ability to understand the nature of treatment, his/her personal consequences, as well as clinical data collection and documentation 3. minimum age is 18 4. written informed consent

Exclusion criteria

Exclusion criteria: 1. malign parathyroid diseases, reoperations 2. inability of the patient to understand the nature of treatment, his/her personal consequences, as well as clinical data collection and documentation 3. less than 18 years old 4. withdrawal of informed consent and data release during investigation

Design outcomes

Primary

Measure	Time frame
1.direct economic assumptions - incision-suture time - simultaneity factor for the personnel involved - total test turnaround time (4t) - material costs 2.contribution margin per case	—

Secondary

Measure	Time frame
1. sensitivity, specificity (50% descending value of PTH after 10 minutes), ppv, ngv (positive and negative predictive value), total accuracy, utilization rate and likelihood ratio for both analytical methods regarding to the prediction that regeneration of biochemical processes in the body take place and recovery is progressive. Calculation according to four-field matrix. 2. set-up times 3. number of surgeries on operation day	—

Measure

Time frame

1. sensitivity, specificity (50% descending value of PTH after 10 minutes), ppv, ngv (positive and negative predictive value), total accuracy, utilization rate and likelihood ratio for both analytical methods regarding to the prediction that regeneration of biochemical processes in the body take place and recovery is progressive. Calculation according to four-field matrix. 2. set-up times 3. number of surgeries on operation day

—

Countries

Germany

Contacts

Public ContactBarbara Leitner

Diakonie-Klinikum Stuttgart Studienzentrale

leitner@diak-stuttgart.de+49 (0)711 991 2434

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026