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To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid at specified timepoints post administration through 24 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (12-month exchange) | Experimental | Travoprost Intracameral Implant Exchanged at Month 12 |
|
| Cohort 2 (3-month exchange) | Experimental | Travoprost Intracameral Implant Exchanged at Month 3 |
|
| Cohort 3 (6-month exchange) | Experimental | Travoprost Intracameral Implant Exchanged at Month 6 |
|
| Cohort 4 (24-month exchange) | Experimental | Travoprost Intracameral Implant Exchanged at Month 24 |
|
| Cohort 5 (21-month exchange) | Experimental | Travoprost Intracameral Implant Exchanged at Month 21 |
|
| Cohort 6 (18-month exchange) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost Intracameral Implant exchanged at Month 12 | Drug | intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS) | month 12 |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS | month 3 |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS | month 6 |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS | month 24 |
| Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS | month 21 |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS | month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Residual Travoprost in Explanted Implant 12 Months Post-administration | percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC) | month 12 |
| Percent Residual Travoprost in Explanted Implant 3 Months Post-administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Stephens | Glaukos Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaukos Clinical Study Site | Yerevan | Armenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40126812 | Derived | Szekely G, Voskanyan LA, Stephens KG, Doan LV, Seal JR, ElMallah MK, Fjield T, Applegate D, Usner DW, Katz LJ, Kothe AC, Navratil T. Aqueous Humor Concentrations of Travoprost Free Acid and Residual Drug in Explanted Implants from Patients Administered a Travoprost Intracameral Implant. Ophthalmol Ther. 2025 May;14(5):989-1003. doi: 10.1007/s40123-025-01130-1. Epub 2025 Mar 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (12-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 12 Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12 |
| FG001 | Cohort 2 (3-month Exchange) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Study Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2019 | Sep 12, 2024 |
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Travoprost Intracameral Implant Exchanged at Month 18 |
|
| Cohort 7 (15-month exchange) | Experimental | Travoprost Intracameral Implant Exchanged at Month 15 |
|
|
| Travoprost Intracameral Implant exchanged at Month 3 | Drug | intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3 |
|
|
| Travoprost Intracameral Implant exchanged at Month 6 | Drug | intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6 |
|
|
| Travoprost Intracameral Implant exchanged at Month 24 | Drug | intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24 |
|
|
| Travoprost intracameral implant exchanged at Month 21 | Drug | intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21 |
|
|
| Travoprost intracameral implant exchanged at Month 18 | Drug | intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18 |
|
|
| Travoprost intracameral implant exchanged at Month 15 | Drug | intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15 |
|
|
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS | month 15 |
percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC |
| month 3 |
| Percent Residual Travoprost in Explanted Implant 6 Months Post-administration | percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC | month 6 |
| Percent Residual Travoprost in Explanted Implant 24 Months Post-administration | percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC | month 24 |
| Percent Residual Travoprost in Explanted Implant 21 Months Post-administration | percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC | month 21 |
| Percent Residual Travoprost in Explanted Implant 18 Months Post-administration | percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC | month 18 |
| Percent Residual Travoprost in Explanted Implant 15 Months Post-administration | percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC | month 15 |
Travoprost Intracameral Implant Exchanged at Month 3 Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3 |
| FG002 | Cohort 3 (6-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 6 Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6 |
| FG003 | Cohort 4 (24-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 24 Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24 |
| FG004 | Cohort 5 (21-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 21 Travoprost intracameral implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21 |
| FG005 | Cohort 6 (18-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 18 Travoprost intracameral implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18 |
| FG006 | Cohort 7 (15-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 15 Travoprost intracameral implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15 |
| COMPLETED |
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| NOT COMPLETED |
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|
| Post-exchange Study Period |
|
only a single eye (defined as the study eye) was analyzed in the study
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (12-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 12 Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12 |
| BG001 | Cohort 2 (3-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 3 Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3 |
| BG002 | Cohort 3 (6-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 6 Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6 |
| BG003 | Cohort 4 (24-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 24 Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24 |
| BG004 | Cohort 5 (21-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 21 Travoprost intracameral implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21 |
| BG005 | Cohort 6 (18-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 18 Travoprost intracameral implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18 |
| BG006 | Cohort 7 (15-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 15 Travoprost intracameral implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15 |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| study eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants | Participants |
| |||||||||||||||
| Type of Disease | clinical diagnosis of disease type (open angle glaucoma or ocular hypertension) | Count of Participants | Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS) | study eyes | Posted | Mean | Standard Deviation | ng/mL | month 12 | eyes | eyes |
|
|
| |||||||||||||||||||||||||
| Primary | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS | study eyes | Posted | Mean | Standard Deviation | ng/mL | month 3 | eyes | eyes |
|
| ||||||||||||||||||||||||||
| Primary | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS | study eyes | Posted | Mean | Standard Deviation | ng/mL | month 6 | eyes | eyes |
|
| ||||||||||||||||||||||||||
| Primary | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS | study eyes | Posted | Mean | Standard Deviation | ng/mL | month 24 | eyes | eyes |
|
| ||||||||||||||||||||||||||
| Primary | Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS | study eyes | Posted | Mean | Standard Deviation | ng/mL | month 21 | eyes | eyes |
|
| ||||||||||||||||||||||||||
| Primary | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS | study eyes | Posted | Mean | Standard Deviation | ng/mL | month 18 | eyes | eyes |
|
| ||||||||||||||||||||||||||
| Primary | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration | concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS | study eyes | Posted | Mean | Standard Deviation | ng/mL | month 15 | eyes | eyes |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Residual Travoprost in Explanted Implant 12 Months Post-administration | percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC) | explanted travoprost intracameral implants | Posted | Mean | Standard Deviation | percentage of initial | month 12 | eyes | eyes |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Residual Travoprost in Explanted Implant 3 Months Post-administration | percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC | explanted travoprost intracameral implants | Posted | Mean | Standard Error | percentage of initial | month 3 | explanted implants | explanted implants |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Residual Travoprost in Explanted Implant 6 Months Post-administration | percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC | explanted travoprost intracameral implants | Posted | Mean | Standard Deviation | percentage of initial | month 6 | explanted implants | explanted implants |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Residual Travoprost in Explanted Implant 24 Months Post-administration | percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC | explanted travoprost intracameral implants | Posted | Mean | Standard Deviation | percentage of initial | month 24 | explanted implants | explanted implants |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Residual Travoprost in Explanted Implant 21 Months Post-administration | percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC | explanted travoprost intracameral implants | Posted | Mean | Standard Deviation | percentage of initial | month 21 | explanted implants | explanted implants |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Residual Travoprost in Explanted Implant 18 Months Post-administration | percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC | explanted travoprost intracameral implants | Posted | Mean | Standard Deviation | percentage of initial | month 18 | explanted implants | explanted implants |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Residual Travoprost in Explanted Implant 15 Months Post-administration | percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC | explanted travoprost intracameral implants | Posted | Mean | Standard Deviation | percentage of initial | month 15 | explanted implants | explanted implants |
|
|
initial travoprost intracameral implant period plus 4 weeks post-exchange
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (12-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 12 Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12 | 1 | 30 | 1 | 30 | 4 | 30 |
| EG001 | Cohort 2 (3-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 3 Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3 | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Cohort 3 (6-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 6 Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6 | 0 | 30 | 0 | 30 | 5 | 30 |
| EG003 | Cohort 4 (24-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 24 Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24 | 0 | 30 | 0 | 30 | 3 | 30 |
| EG004 | Cohort 5 (21-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 21 Travoprost Intracameral Implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21 | 1 | 30 | 1 | 30 | 0 | 30 |
| EG005 | Cohort 6 (18-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 18 Travoprost Intracameral Implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18 | 0 | 30 | 0 | 30 | 1 | 30 |
| EG006 | Cohort 7 (15-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 15 Travoprost Intracameral Implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15 | 0 | 30 | 0 | 30 | 1 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corona virus infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Iridodialysis | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Hyphaema | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
Study was open-label, non-randomized and conducted at a single site; however, the endpoints were objective and analyses of aqueous humor concentrations of travoprost free acid and of residual travoprost in explants were performed by a third party
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Glaukos Corporation | 714-478-2287 | ldoan@glaukos.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2022 | Sep 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|
| Ocular hypertension |
|
| eyes |
|
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| eyes |
|
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| eyes |
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| eyes |
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| eyes |
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| eyes |
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| eyes |
|
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| explanted implants |
|
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| explanted implants |
|
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| explanted implants |
|
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| explanted implants |
|
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| explanted implants |
|
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| explanted implants |
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|