An interventional study of Point Digit in Amputation; Traumatic, Hand, sponsored by Point Designs. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Point Designs · Not applicable, Interventional, and Device feasibility
The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's enrollment of 7 is below the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →Point Designs is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient is temporarily fit with Point Digit partial hand prosthetic system
Device: Point Digit
The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-1: System Comfort Validation Test
User wears Point Digit(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be comfortable for a full day's use. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (8 hours)
VAL-2: Unilateral Function Validation Test
User flexes and extends the Point Digit(s) without using contralateral hand (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall allow the user to flex and extend finger without their second hand. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
VAL-3.1: System Robustness Validation Test With 25 lb Bag
User lifts a 25 lb. bag with Point Digit(s) (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
VAL-3.2: Robustness Validation Test With Hammer
User grips a hammer with Point Digit(s) and drives a nail into a piece of wood (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
VAL-4: Object Release Validation Test
User releases Point Digit(s) while performing an active grasp by pressing the dorsal button (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be releasable while performing active grasps. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
VAL-5: Position Function Validation Test
User positions Point Digit(s) into each of the locking positions (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a smooth ratcheting mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
VAL-6: Extension Function Validation Test
User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a reliable auto spring-back mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
VAL-7: Grip Functions Validation Test
User grips a 5 lb. cylindrical smooth object using Point Digit(s) for 10 seconds (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have high grip surface friction. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
VAL-8: Fine Motor Function Validation Test
User picks up 1 coin from a smooth tabletop (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a pronounced fingernail. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
VAL-9: Overall Function & Robustness Validation Test
User performs VAL-1 through VAL-8 (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robustly attached to mounting system. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (8 hours)
| Milestone | Prosthesis |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
User wears Point Digit(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be comfortable for a full day's use. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-1: System Comfort Validation Test | 100 |
User flexes and extends the Point Digit(s) without using contralateral hand (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall allow the user to flex and extend finger without their second hand. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-2: Unilateral Function Validation Test | 100 |
User lifts a 25 lb. bag with Point Digit(s) (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-3.1: System Robustness Validation Test With 25 lb Bag | 100 |
User grips a hammer with Point Digit(s) and drives a nail into a piece of wood (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-3.2: Robustness Validation Test With Hammer | 100 |
User releases Point Digit(s) while performing an active grasp by pressing the dorsal button (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be releasable while performing active grasps. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-4: Object Release Validation Test | 100 |
User positions Point Digit(s) into each of the locking positions (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a smooth ratcheting mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-5: Position Function Validation Test | 100 |
User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a reliable auto spring-back mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-6: Extension Function Validation Test | 100 |
User grips a 5 lb. cylindrical smooth object using Point Digit(s) for 10 seconds (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have high grip surface friction. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-7: Grip Functions Validation Test | 100 |
User picks up 1 coin from a smooth tabletop (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall have a pronounced fingernail. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-8: Fine Motor Function Validation Test | 100 |
User performs VAL-1 through VAL-8 (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit shall be robustly attached to mounting system. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Digits were mounted to the socket. Then, each participant attempted the validation test.
| % of participants who Passed test | Prosthesis |
|---|---|
| VAL-9: Overall Function & Robustness Validation Test | 100 |
Collected over an average of 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prosthesis | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Prosthesis |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Prosthesis |
|---|---|
| Female | 2 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Prosthesis |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Prosthesis |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
Plan to share: No
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